Senior Director, Quality Control

Vir Biotechnology, Inc. San Francisco , CA 94118

Posted 2 months ago

Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Our current development pipeline consists of five product candidates targeting hepatitis B virus, influenza A, human immunodeficiency virus and tuberculosis.

Vir Bio is seeking an experienced Quality Control director to lead QC operations and program leadership in support of clinical development, with a clear vision towards late stage GMP-compliant QC systems and commercialization. This position requires partnering with Analytical Development to ensure methods are GMP-ready, establishing and leading method lifecycle programs, leading the selection and management of third party Contract Testing Laboratories (CTL), authoring/reviewing applicable CMC sections of regulatory submissions, defending the product control strategy in regulatory filings and during inspections, and providing strategic oversight of stability and specification programs. This individual will be instrumental in developing the framework of the QC infrastructure and in creating the long-term vision for the department. As the department head, this individual will also be responsible for supporting due diligence activities associated with acquisitions and partnerships.

The QC head will provide the organization with decision-making, direction and strategic oversight of in-house activities as well as activities conducted at CTLs. The position requires a strong knowledge of cGMP/ICH/FDA/EU regulations as well as people management and team leadership skills.

RESPONSIBILITIES

  • Develop a departmental vision and structure for the QC function at the Vir San Francisco site

  • Grow and manage the QC organization, including performance management, career development, and mentorship of staff

  • Work as a member of cross-functional teams to represent QC and support clinical development programs

  • Create programs and provide strategic oversight of assay lifecycle programs, both in house and at CTLs

  • Author and/or review CMC sections for all regulatory filings and defend the Vir Bio control strategy during regulatory inspections

  • Provide high level leadership of stability programs, design of assay release panels, and development of specifications

  • Provide strong leadership in troubleshooting and complex problem solving

  • Review/approve QC SOPs, policies, analytical test methods, protocols and reports, as needed

  • Manage and approve change controls, deviations, CAPAs, OOT/OOS investigation reports

  • Manage project timelines and budget to meet corporate goals

QUALIFICATIONS AND EXPERIENCE

  • Strong leadership and people management skills and demonstrated ability to work in a productive and collaborative cross-functional manner

  • Extensive experience with analytical test method optimization, validation, and transfer

  • Strong technical knowledge and hands-on experience in one or more of the following areas: potency assays, virology assays, PCR, sequencing, analytical chemistry methods. Ability to lead method lifecycle activities across all analytical methodologies.

  • Strong knowledge of cGMP/ICH/FDA/EMA regulations and quality systems

  • Highly collaborative team player who fosters open communication and ensures involvement of key stakeholders in decision-making

  • Prior experience in QC/analytical for viral drug products or vectors, protein/antibody biologics, siRNA therapeutics, or other biological/large molecule modalities

  • Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects

  • Strong written and verbal communication skills, and experience with representation/leadership on inter-disciplinary and cross-functional teams

EDUCATION

  • BS/MS in a relevant scientific discipline and 20+ years, or PhD and 12+ years, of experience in GMP analytical operations

  • Experience must include 5+ years in management and team leadership roles

VIR is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

The Human Resources team manages the recruitment and employment process for Vir. Unsolicited resumes sent to Vir from recruiters do not constitute any type of relationship between the recruiter and Vir and do not obligate Vir to pay fees should we hire from those resumes. Recruiters are requested not to contact or present candidates directly to our hiring manager or employees.


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