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Vice President, Quality Assurance

Location: Chicago, IL

Xentria is a patient-centric biotech company focused on novel biologics and biosimilars. Our first program is XT MAB 16, a monoclonal antibody for sarcoidosis. XT MAB 16 has received Orphan Drug Designation. The Vice President, Quality Assurance is responsible for overseeing and directing the development, implementation and maintenance of quality management practices and systems as governed by GCP, GMP and GLP (GxP) regulations, to ensure compliance with internal policies, business objectives, procedures, and external regulations and standards.

Essential Duties and Responsibilities

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.


  • Provides strategic direction, develops and maintains the company’s Quality Assurance Management System (QMS).
  • Ensures quality and operational regulatory compliance; acts as a subject matter expert for quality investigations, documentation systems, training programs, internal/external audits, and vendor assurance programs.  
  • Develops and maintains positive working relationships with service provider organizations; establishes appropriate service provider qualifications and disqualifications.
  • Participates in the selection and qualification process of clinical, nonclinical, and manufacturing vendors/contractors.
  • Participates in the selection, qualification and overseeing of services of local quality consultants in various geographic regions where GXP contracted activities are needed.  
  • Oversees clinical/pre-clinical program quality audit planning, execution and resolution of issues.
  • In consultation with the CMC group, oversees GMP master documentation including master batch records, validation protocols and QC test methods.
  • Supports regulatory inspections.
  • Handles product complaints, changes and deviations; leads / supports investigations to resolve quality issues.
  • Designs and oversees the execution of GXP and SOP training programs; develops and maintains centralized system for GXP documents including record control, archival, protection and access.
  • Develops the Quality Assurance operating budget and monitors expenditures.
  • Identifies GXP and other key compliance requirements and provides leadership in promoting awareness and understanding of global regulatory compliance expectations.
  • Ensures harmony across SOPs and shared responsibilities.
  • Leads the Audit Program management process, including assessment of internal and external (outsourced) GXP operations.
  • Works with cross functional and other internal project teams to effectively support process and quality enhancement initiatives. 
  • In cooperation with the CMC group, manages the approval process for raw materials, packaging materials, intermediate and finished products as per the appropriate regulations and site procedures.
  • In cooperation with the CMC group, manages the testing program for materials and products, including the execution of the stability monitoring programs.
  • Provides leadership in the development of change strategies that align resources and encourage a collaborative, supportive and high performing work environment.
  • Partners with senior management to ensure that best practices and proper training are adopted including compliance with all quality policies, quality improvement initiatives and ensuring appropriate quality systems are implemented and maintained. 
  • Adheres to company’s policies and supports management decisions and goals in a positive, professional manner



Supervisory Responsibilities

No direct reports associated at this time.


Competencies

  • Interpersonal
  • Teamwork
  • Problem Solving
  • Quality Management
  • Judgement
  • Dependability
  • Ethics

Qualifications

  • Strong knowledge of US and international GCP requirement practices, global regulations regarding clinical development, auditing and regulatory inspection is required.
  • Ability to work in a dynamic, start-up organization with aggressive timelines and multiple deliverables.
  • Must have professional communication skills, strong independent time management skills and the ability to manage multiple projects concurrently in an organized fashion.
  • Strong technical writing skills; ability to write clear quality positions statements, risk-based audit reports, and procedures.
  • Extensive experience in building GCP systems and processes.
  • Direct experience successfully interacting with regulatory authorities.
  • Hands-on experience with increasing responsibility in a Quality Assurance/Quality Systems Development function and at least 8 years in a leadership capacity. 

Education and / or Experience Required

• Bachelor's degree in Clinical or Scientific discipline. 

• Advance degree preferred.

• Minimum of 10 years of experience in the pharmaceutical R&D industry, of which a minimum 8 years should be hands-on GCP Quality Assurance experience.


Computer Skills

Microsoft Word, PowerPoint, Excel, TrackWise Digital preferred but not required 


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

The noise level in the work environment is usually moderate.


AAP/ EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled. 


Travel

Ability to travel up to 20% (domestic and international)


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About Us

Headquartered in Chicago, the company is dedicated to R&D, clinical science, manufacturing, and commercialization while striving to treat the clinical and social disease burdens while fostering sustainable growth. Xentria, whose name stems from the word “centrality” was founded in 2020 and is an innovative biopharmaceutics company whose primary focus is to build an expansive product pipeline of cost-effective and efficacious treatments to address critical unmet needs for patients suffering from rare, immunologic, metabolic, and musculoskeletal diseases, as well as oncology.

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