Life At Xentria

Summary

Our name, Xentria, is inspired by “centrality.” It describes our dedication to delivering adaptive approaches to ambitious drug innovation through authentic life-sciences partnerships. Established in 2020, we are a patient-centric biotech company focused on development of novel biologics and biosimilars. We collaborate with biopharmaceutic communities to create innovative solutions to challenging drug development. Our first program, XT MAB 16, is a monoclonal antibody for sarcoidosis, that has received Orphan Drug Designation. 

Xentria is seeking an experienced and energetic Clinical Project Manager (CPM) to join their Clinical Operations team. This candidate will report Director of Clinical Operations. The CPM will be responsible for overseeing all aspects of clinical trial activities on assigned studies. This will include managing outside vendors in the execution of clinical trials and development of relationships between the Sponsor and site personnel.

Essential Duties and Responsibilities

Essential Duties and Responsibilities include the following. Other duties may be assigned.

• Plans and implements clinical research studies within budget and on schedule.
• Participates in and facilitates CRO/vendor selection process for outsourced activities
• Manages CRO interactions, including sponsor oversight of operational functional activities (e.g., study  management, monitoring, site management, project master files)
• Works with CRO to develop and revise scope of service agreements, budgets, plans and detailed timelines, and ensures that performance expectations are met
• Prepares and/or reviews/approves study-related documents (e.g., Monitoring Plan, Laboratory Manual, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines)
• Coordinates and leads study team meetings and update the Clinical Team on timelines and milestones for the study.
• Contributes to the development of study documentation including protocol review, creating study manuals, ICFs, and designing CRFs.
• Participates in study site selection; review and update site-specific consent forms; track patient accrual and study progress via standard reports; assure patient eligibility; document protocol deviations/violations; and manage adverse event reporting.
• Oversees clinical monitoring from site qualification to site closure visits and assure the integrity of clinical data with respect to accuracy, accountability, and documentation through review of case report forms, source documents, and medical records.
• Evaluates and analyzes clinical data.
• Provides input to Clinical Study Reports and Investigator Brochures, including data cleaning, listing review, and report writing.
• Reviews and negotiates contracts & budgets.
• Ensures that study documentation is maintained according to applicable regulations, industry-accepted standards, and SOPs that govern clinical studies both in the field and in-house.
• Develops SOPs, work instructions, and standardized forms to define Clinical Operations processes within a small but growing team.
• Collaborates with Clinical, Regulatory, and Quality team members to ensure compliance of department/study activities with FDA/EMA regulations, guidelines, and principles of ICH GCP and company SOPs. Participates in the development, review and implementation of departmental SOPs and processes.

Supervisory Responsibilities

No direct reports associated at this time.

Competencies

• Teamwork
• Professionalism
• Judgement
• Ethics
• Interpersonal
• Project Management

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Demonstrates advanced knowledge of and appropriate experience of relevant software packages (e.g., Microsoft Project, Word, Excel) and the company’s systems and programs.
• Experience in rare disease, orphan or neurology is highly desirable. 
• Must have strong oral and written communication skills with monitoring, study management, and SOP-development experience. 
• Must be highly adaptable, proactive, deadline- and detail oriented, and will maintain a high level of professional expertise through recent industry training and familiarity with clinical research publications. 
• Ability to work independently under general direction in a fast paced environment

Education and / or Experience Required

Required:

• B.S. and/or M.S. degree in a scientific discipline
• At least three years of direct global clinical project management experience in the pharmaceutical or biotech setting
• Proficient to expert knowledge of GCP and EMA/FDA regulations
• Experience overseeing multiple vendors and CROs
• 
  

Preferred:

• Experience with early access programs
• PMP certification or equivalent 

Travel

Up to 25% domestic and/or international travel expected with routine travel to Chicago office.

Computer Skills

Microsoft Word, Excel, PowerPoint and Project

Physical Demands

While performing the duties of this Job, the employee is frequently required to stand; walk; sit and talk or hear. The employee must occasionally lift and/or move up to 20 pounds. 

Work Environment

This is a remote position.

AAP/ EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.

Summary

Our name, Xentria, is inspired by “centrality.” It describes our dedication to delivering adaptive approaches to ambitious drug innovation through authentic life-sciences partnerships. Established in 2020, we are a patient-centric biotech company focused on development of novel biologics and biosimilars. We collaborate with biopharmaceutic communities to create innovative solutions to challenging drug development. Our first program, XT MAB 16, is a monoclonal antibody for sarcoidosis, that has received Orphan Drug Designation. 

Xentria is seeking a clinical-focused Medical Writer to contribute to clinical document and manuscript development across Xentria's portfolio.

Essential Duties and Responsibilities

Essential Duties and Responsibilities include the following. Other duties may be assigned.

• Serves as primary author who writes and provides input on routine documents such as clinical study reports and study protocols, investigator brochures, manuscripts. 
• Researches scientific and regulatory information in order to write submission documents, edit complex clinical and scientific and program level documents, including IBs, INDs, and regulatory submissions.
• Reviews routine documents prepared by junior team members. May provide training and mentorship for junior writers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge.
• Develop and maintain Xentria Style Guide and insure consistency across all documents. 
• Ensures compliance with quality processes and requirements for assigned documents. Provides input on and independently develops best practices, methods and techniques for achieving optimal results, including various client-specific processes.
• Work with data management, statisticians, and clinical teams, as well as potentially sponsors and KOLs to review protocol development and interpret clinical trial data for study summaries and reports. 
• Collaborate Interface with other departments (Clinical, R&D, , Clinical Operations, Operations, etc.) as needed. 
• Maintain chronological and operational trackers as needed. and perform other appropriate administrative duties, such as preparing correspondence (records of contact), filing, submissions to conferences and journals and related follow-up, where necessary. 

Supervisory Responsibilities

None at this time.

Competencies

• Teamwork
• Professionalism
• Judgement
• Ethics
• Interpersonal
• Project Management

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Ability to write, edit, or otherwise facilitate completion of all documents including final reports, data summaries, manuscripts, abstracts, posters, slide decks, etc. 
• Ability to analytically evaluate and interpret references in literature, and clinical and scientific data; ability to define data presentation to meet key messages developed by the clinical and therapeutic teams. 
• Goal-oriented with an ability to set detailed timelines for completion of assigned projects and ensure efficient, timely completion. 
• Excellent communication, interpersonal, negotiation and project management skills 
• Strong attention to detail with well-developed organization, research, and investigative skills. 
• Experience with interpretation of data, summarizing data analyses. 
• Ability to work in an ever-changing environment; demonstrated ability to multitask and achieve deadlines and targets under time constraints. 
• Strong time management skills, with the ability to work on multiple projects simultaneously. 
• Ability to work well in a team environment, with the ability to work effectively independently. 

Education and / or Experience Required

• BS/BA in biological science, engineering or a similar technical discipline preferred.
• 3+ years of related experience required
• Experience required in medical writing, clinical affairs, regulatory affairs, with a strong preference to those with similar work experience in the biopharmaceutic industry.

Travel

Up to 10% domestic and/or international travel expected with routine travel to Chicago office.

Computer Skills

Microsoft Word, Excel, PowerPoint

Physical Demands

While performing the duties of this Job, the employee is frequently required to stand; walk; sit and talk or hear. The employee must occasionally lift and/or move up to 20 pounds. 

Work Environment

This is a remote position.

AAP/ EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.

Summary

Our name, Xentria, is inspired by “centrality.” It describes our dedication to delivering adaptive approaches to ambitious drug innovation through authentic life-sciences partnerships. Established in 2020, we are a patient-centric biotech company focused on development of novel biologics and biosimilars. We collaborate with biopharmaceutic communities to create innovative solutions to challenging drug development. Our first program, XT MAB 16, is a monoclonal antibody for sarcoidosis, that has received Orphan Drug Designation. 

The Director of Clinical Operations will ensure world class clinical trial planning and execution in accordance with associated regulatory guidelines. This includes being responsible for clinical study conduct such as site selection, contract negotiations study start-up and real time data delivery, providing leadership and resolution of trial and/or program specific issues to deliver high-quality clinical trial results.

Essential Duties and Responsibilities

Essential Duties and Responsibilities include the following. Other duties may be assigned.

• Provides clinical operations leadership and oversight for all study activities (site identification and selection, enrollment models, clinical supply planning, CRO selection and negotiations, budget planning and trial execution).
• Determines operational processes, systems and standards that need to be adopted and implemented consistently to support effective clinical program management and compliance across trials and locations (e.g., SOPs, best practices, training programs).
• Supports implementation of a strong quality culture within Clinical Operations ensuring all clinical trials are conducted according to ICH/GCP requirements, corporate/departmental SOPs/ policies and industry best practices.
• Shares accountability for the planning process to ensure clinical studies are aligned with the overall clinical strategy and meet overall strategic goals for the company (budget, timeline and quality metrics).
• Develops and implement clinical monitoring training program to include GCP, monitoring and site management skills, and protocol-specific training (in collaboration with CMO, Clinical and Medical Monitors- internal and external vendors).
• Collaborates with legal, finance and corporate development functions to maintain continuity in planning, negotiation, forecasting and reporting metrics and milestones.
• Oversees and provides relationship management support for external vendors and clinical partners to ensure delivery of clinical objectives within established timelines and budget.
• Ensures the clinical team keeps abreast of the most effective industry practices to ensure successful delivery of clinical trials.
• Plays a lead role in the development of the clinical operations/clinical trial sourcing strategy in a start-up environment.
• Implements and oversees/mentors data management, programming and medical writing functions and ensure stage-appropriate resource allocation.

Supervisory Responsibilities

Supervisory responsibilities including 1-5 direct reports.

Competencies

• Teamwork
• Professionalism
• Judgement
• Ethics
• Interpersonal
• Project Management

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Deep understanding of comprehensive global pharmaceutical regulatory requirements and strategic implications for clinical operations; including understanding of clinical research principles, drug development process, FDA & ICH, GCP, GCDMP and related regulatory requirements & guidelines.
• Clinical experience in all phases of clinical development including IND filings and registration experience is a plus.
• Experience with rare disease or oncology trials and programs leading to accelerated approval is highly desired.
• Proven experience in CRO/vendor selection, contracting, oversight and relationship management.
• Demonstrated excellence in global clinical program/trial management including complex project management and effective management of multiple projects/priorities and budgets.

Education and / or Experience Required

• Bachelor’s degree in health sciences or related field; Masters or PhD preferred.
• Minimum 10 years’ experience in Clinical Operations in biotech or pharma environment; strong oncology therapeutic experience required.

Travel

Up to 25% domestic and/or international travel expected with routine travel to Chicago office.

Computer Skills

Microsoft Word, Excel, PowerPoint and Project

Physical Demands

While performing the duties of this Job, the employee is frequently required to stand; walk; sit and talk or hear. The employee must occasionally lift and/or move up to 20 pounds. 

Work Environment

This is a remote position.

AAP/ EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.

Summary

Our name, Xentria, is inspired by “centrality.” It describes our dedication to delivering adaptive approaches to ambitious drug innovation through authentic life-sciences partnerships. Established in 2020, we are a patient-centric biotech company focused on development of novel biologics and biosimilars. We collaborate with biopharmaceutic communities to create innovative solutions to challenging drug development. Our first program, XT MAB 16, is a monoclonal antibody for sarcoidosis, that has received Orphan Drug Designation. 

Xentria is seeking a Staff Accountant to support the Company’s high growth objectives, goals and strategies under the guidance of the VP of Finance. The Staff Accountant position will lead the month end close process, accounts payable, and will be responsible for delivering accurate and timely financial information to the business leaders. 

Essential Duties and Responsibilities

Essential Duties and Responsibilities include the following. Other duties may be assigned.

• Responsible for the overall month-end close process including revenue, inventory, fixed assets, prepaids and supply chain accounting, reconciliation and analysis. 
• Provides guidance, insight and technical expertise as it relates to general accounting. 
• Responsible for calculating monthly accruals/reserves including chargebacks, prompt pay discounts and inventory reserves. 
• Works collectively with team in identifying new process and system improvement opportunities and identifies, resolves or escalates repetitive or complex discrepancies.
• Oversees corporate accounts payable and accounts receivable functions.
• Reviews results on a monthly basis and provides variance analysis.
• Develops/maintains accounting policies, procedures and tools/templates to comply with U.S. GAAP.
• Prepares and maintains accounting documentation, including technical accounting research on complex accounting issues and documents the position papers. 
• Develops, implements and reviews documentation for internal control compliance and testing. 
• Independently and timely performs non-recurring, one-off projects and other analyses as delegated by the VP of Finance.
• Develop into an integral member of the Finance Team and backup to the VP of Finance through demonstrating leadership of the Finance Team, when necessary, including developing the confidence to independently make decisions. 

Supervisory Responsibilities

None at this time.

Competencies

• Business Acumen
• Positive Attitude
• Business/Financial Acumen
• Ethics and Values
• Motivation
• Critical Thinker
• Team Player
• Strong Analytical Skills
• Technologically Proficient
• Professionalism

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Ability to utilize advanced finance and accounting experience to manage assigned workload.
• Working knowledge of corporate financial statements, including balance sheet, income statement, and related analytics, including cost center review and comparison to budget and forecast.
• Excellent communication skills.
• Able to quickly establish a personal brand within the organization to drive cross-functional collaboration.
• Curious mindset that proactively seeks understanding and feedback.
• Understands ASC 606 and the impact on the company’s policies and procedures.

Education and / or Experience Required

Required: 

• Bachelor’s degree in Accounting, Finance or related area is required.
• CPA preferred.    
• Pharmaceutical industry experience preferred.
• Minimum of 5-6 years of experience with a mixture of public accounting (Big Four preferred).
• Solid understanding of U.S. GAAP, SEC financial reporting, and management reporting and analysis.

Travel

Up to 5% domestic and/or international travel expected with routine travel to Chicago office.

Computer Skills

Microsoft Word, Excel, PowerPoint

Physical Demands

While performing the duties of this Job, the employee is frequently required to stand; walk; sit and talk or hear. The employee must occasionally lift and/or move up to 20 pounds. 

Work Environment

This is a remote position.

AAP/ EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.

Summary

Our name, Xentria, is inspired by “centrality.” It describes our dedication to delivering adaptive approaches to ambitious drug innovation through authentic life-sciences partnerships. Established in 2020, we are a patient-centric biotech company focused on development of novel biologics and biosimilars. We collaborate with biopharmaceutic communities to create innovative solutions to challenging drug development. Our first program, XT MAB 16, is a monoclonal antibody for sarcoidosis, that has received Orphan Drug Designation. 

Xentria is seeking a Clinical Trial Liaison to serve as a value-added resource to sites and investigators to support Xentria’s clinical development programs. The Clinical Trial Liaison will integrate scientific and clinical knowledge to support the successful execution of clinical studies in compliance with investigational plans, applicable regulations, and in line with identified business goals and objectives by coordinating with internal and external stakeholders while providing logistical support throughout the entire process. You will also work to build relationships, where appropriate, with patient groups, scientific organizations, and advocacy organizations.

Essential Duties and Responsibilities

Essential Duties and Responsibilities include the following. Other duties may be assigned.

• Enhance clinical trial execution and enrollment through building deep relationships with study investigators and research staff.
• Work with the clinical investigators and site staff across the US and internationally, to provide disease area education; support enrollment and retention initiatives; identify, mitigate, and provide solutions to enrollment hurdles.
• Manages stakeholder mapping in rare disease landscape
• Organizes, schedules, and facilitates cross-functional team meetings to exchange information
• Establish and manage relationships with alliance partners
• Develops recommendations and brings forward key decisions needed from Senior Management in support of project and business objectives.
• Demonstrated ability to plan, implement, and manage multiple projects in a fast-paced environment
• Strong analytic skills for strategic review and assessment of site engagement plans
• Contribute to medical writing activities including abstracts, white papers, educational assets, the preparation of clinical documents, study design protocols, and others as needed
• Establish and maintain long-term collaborative relationships with clinical trial investigators, their research staff, and KOLs
• Support business development and due diligence activities as needed.
• Build and cultivate relationships with disease area experts (KOLs), clinical investigators, and research staff.
• Work cross functionally within Xentria and with sites, investigators, and KOLs to facilitate the conduct and successful completion of clinical trials.
• Proactively recognize issues and barriers to enrollment and work to develop solutions.
• Identify and address concerns from sites regarding clinical trial participation.
• Attend relevant regional, national, and international meetings in the relevant therapeutic area(s)
• Engage in peer-to peer discussions with investigators and researchers about trial progress.

Supervisory Responsibilities

No direct reports associated at this time.

Competencies

• Teamwork
• Professionalism
• Judgement
• Ethics
• Interpersonal
• Project Management
• Organization

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• High levels of flexibility, creativity, the ability to work well with a team, and problem-solving are required to be successful.  
• Excellent organization, attention to detail, and ability to maintain detailed and accurate records
• Ability to develop, maintain and grow external partner relationships as well as coordinate and communicate with internal teams and serve as the liaison between Xentria and external stakeholders. 
• Proactive, energetic, self-assured professional with personal integrity, the ability to develop healthy interpersonal relationships
• Solid understanding of alliance management in rare disease landscapes
• Ability to manage time and resources to prioritize tasks and accomplish set goals efficiently
• Successfully navigate in a fast-paced environment with changing priorities and constraints
• Ability to collaborate, and contribute both as an individual and as a team member

Education and / or Experience Required

• Bachelor’s Degree in a business-related discipline.
• A minimum of 1-2 years of International Clinical Trial Management experience in biotech or related field.

Travel

Up to 10% domestic and/or international travel expected with routine travel to Chicago office.

Computer Skills

Microsoft Word, Excel, PowerPoint and Project (preferred)

Physical Demands

While performing the duties of this Job, the employee is frequently required to stand; walk; sit and talk or hear. The employee must occasionally lift and/or move up to 20 pounds. 

Work Environment

This is a remote position.

AAP/ EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.

Summary

Our name, Xentria, is inspired by “centrality.” It describes our dedication to delivering adaptive approaches to ambitious drug innovation through authentic life-sciences partnerships. Established in 2020, we are a patient-centric biotech company focused on development of novel biologics and biosimilars. We collaborate with biopharmaceutic communities to create innovative solutions to challenging drug development. Our first program, XT MAB 16, is a monoclonal antibody for sarcoidosis, that has received Orphan Drug Designation. 

Xentria is seeking an experienced Director of Clinical Quality Assurance to join their Quality Assurance team. This candidate will report directly to the Vice President of Quality Assurance. The Director of Clinical Quality Assurance will provide strong leadership and clinical development experience to support Xentria’s Quality Assurance and clinical compliance programs. This role will involve ongoing interaction with internal project team members, vendors, partners and project teams, influencing these internal and external stakeholders to successfully embed a robust Quality Assurance culture. This is a high-visibility role and will be directly involved in developing and continuously improving Quality Management System at Xentria. Director of Clinical Quality Assurance will be relied upon as a subject matter expert in GCP and Clinical Compliance with respect to the planning, execution, and close-out of clinical studies.

Essential Duties and Responsibilities

Essential Duties and Responsibilities include the following. Other duties may be assigned.

Quality Systems:

• Participate in the establishment, maintenance and improvement the Quality Management System and associated practices.

• Execute and oversee the clinical development oversight program across Clinical Development and implement quality throughout clinical trial execution. 

• Determines, evaluates and investigates GCP Quality Events and determines adequacy of reporting and the potential impact on the study.

• Participate in inspections performed by FDA and international regulatory agencies; also, audits performed by partners.

• Proactively identify analyses and leverage quality indicators and data to identify potential trends and risks to address and complete risk-based QA assessments and to support the implementation of associated risk mitigation strategies.

• Assists in developing a robust clinical (GCP) quality system, provides business-level leadership, fosters best practices, and mentors and consults on compliance techniques across the development and operations organizations

• Deliver input (e.g., GCP) on relevant projects to the Functional Areas and Quality Management Review

• Process Deviations, Quality Issues, CAPAs, and changes as required in the clinical studies.

• Develop and support the issuance of Controlled Documents (e.g., Policy, SOPs, KPIs)

• Support and manage computer system validation activities for GXP-related systems

• Provide suggestions for continuous quality improvement in GxP and, specifically, GCP.

• Maintain expert up-to-date knowledge on GCP legislation and relevant parts of GxP guidelines and practices and ensure that the information is distributed and acknowledged by relevant parts of the Xentria Organization

• Facilitate review of potential Serious Breach and Urgent Safety Measure assessments arising from assigned clinical program

• Support Quality department for all GXP areas (e.g., GMP, GLP)

Training:

• Provide input for GCP and other relevant training in QA and the GCP area.

• Support the development and assessment of the corporate training management systems and assessments

Audits/Inspections:

• Develop and maintain the GCP audit strategy in collaboration with senior QA leadership.

• Prepare individual audit plans and audit/risk mitigation plans for larger projects/programs in support of the Xentria Audit Program.

• Plan, conduct, reported, and follow-up of internal audits, vendor (CRO) and site audits in accordance with current procedures

• Proactively assesses internal and external vendor compliance issues and risks, providing strong leadership and expertise in setting and maintaining compliance standards

• Clearly communicate and report (verbally and in writing) audit outcomes to the Xentria organization and escalate quality issues as required.

• Support Xentria Inspection Readiness activities

Clinical Quality:

• Responsibilities to collaborate/support clinical trial management, clinical development, and the implementation of Risk Based Quality Management within assigned program(s); identifying and evaluating the remediation of fundamental risks and quality issues internally, at Vendors and clinical sites; and collaborating with stakeholders to ensure inspection readiness for assigned programs, laying the foundation for successful outcomes during submission-related and unannounced inspections

• Develop and maintains effective working relationships with stakeholder functions to achieve GCP QA and compliance goals.

• Provide input to the preparation of documents for internal reports, external partner reports and/or regulatory filings 

• Represent QA in study team(s) where relevant and participate as appropriate to ensure clinical trials are conducted in compliance with clinical protocols, GCP and other regulatory requirements.

• Responsible for QA review of key study documentation, SOPs, Vendor documentation, and relevant submission documentation. 

• Lead a team of program oversight colleagues and ensure their continuous development 

• Partner with key vendor QA functions to remediate risk and manage emerging issues 

• Assists with developing, implementing and communicating the strategic vision for GCP compliance to maximize employee focus, while maintaining a strong independent role for QA and compliance-related decisions

• Report on Quality activities on a regular basis to the Executive and Senior Leadership Teams, ensuring accurate and timely reporting of the relevant Key Performance Indicators

• Evaluate all Quality systems and processes and recommend and implement appropriate enhancements to ensure the achievement of Xentria’s near-term and long-term objectives.

• Lead efforts and collaborate with all internal and external partners to ensure readiness of all GxP activities required for inspections associated with clinical product filings.

• Ensure appropriate Quality Leadership of all partner and regulatory authority audits and inspections of the clinical program.

• Facilitate Quality Oversight Committee meetings with Vendors. 

• Provide Quality support for Governance Meetings with select Vendors.

Supervisory Responsibilities

No direct reports associated at this time.

Competencies

• Demonstrated ability to lead people in a positive manner.

• Demonstrated ability to manage multiple and diverse projects concurrently.

• Demonstrated ability to develop positive relationships and collaborations.

• Strong analytical skills; a strategic thinker, planner, and implementer.

• Reliable, dependable, and consistent worker.

• Strong ability to create practical and efficient processes.

• Highly effective interpersonal skills in individual as well as in group settings.

• Strong communication skills, both written and verbal.

• Enthusiastic, genuine, ethical, fair, and loyal to the organization and its vision and goals.

• Results-oriented; able to determine approaches to assignments 

• Problem-solving skills with the ability to analyze situations and/or data while considering future impact and intangible variables  

• Demonstrated attention to detail, accuracy, excellent review and analytical skills in a fast-paced environment  

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Minimum of 20 years’ experience in the pharmaceutical or biotechnology industry with minimum 10 years in a quality leadership role

• Expert knowledge of GxP, FDA, EMA and other regional regulations.

• Experience in multiple disciplines within Quality Assurance and Quality Risk Management, e.g., auditing, GCP oversight, electronic systems management, vendor management, CAPA management, inspection readiness and leadership.

• Established expertise and training in GxP systems

• Functional planning experience and ability to develop functional vision, priorities, and tactics  

• Clinical Site, CRO or Sponsor Clinical Study/Clinical Operations experience 

• Experience with product development lifecycle 

• Experience conducting remote and digital audits

Education and / or Experience Required

Bachelor’s degree in health sciences or related field

Travel

Up to 20% domestic and/or international travel expected with routine travel to Chicago office.

Computer Skills

Microsoft Word, Excel, PowerPoint and Project, Quality Management Systems (e.g. TrackWise, Qualio), electronic Trial Master Files

Physical Demands

While performing the duties of this Job, the employee is frequently required to stand; walk; sit and talk or hear. The employee must occasionally lift and/or move up to 20 pounds.

Work Environment

This is a remote position.

AAP/ EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.