Vir is a clinical-stage immunology company with a compelling mission: "A World Without Infectious Disease". We are focused on combining immunologic insights with cutting-edge technologies. We have 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 product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus.
We believe the success of our colleagues drives the success of our Mission. We have an ongoing commitment to creating a company passionate about equality, inclusion, and respect. When everyone feels supported and encouraged to give at their best, we will collectively deliver outstanding results.
VIR seeks a Senior Director of Clinical Quality Assurance (cQA) to lead the company's Clinical Quality Assurance program. The position involves leading the global clinical quality team as well as partnering with Vir's clinical team to oversee quality related activities at clinical vendors, investigator sites and regulatory agencies. The incumbent will lead the development and improvements of Good Clinical Practice (GCP)-related quality systems to ensure clinical trials are conducted in accordance with appropriate regulations and ICH guidelines. The candidate will be responsible for oversight of regulatory inspections as well as audits of vendors, study sites, as well as study specific quality issues. The candidate must actively collaborate with VIR's clinical stakeholders and act as a catalyst for continuous process improvement.
RESPONSIBILITIES AND LEARNING OPPORTUNITIES:
- Lead the development and maintenance of GCP-related quality system SOPs in compliance with all applicable regulatory and ICH requirements and to align with existing company policy. Ensure clinical trials are performed in accordance with applicable study protocols and are in compliance with all applicable regulatory requirements.
- Collaborate with cross functional Inspection Readiness/Preparedness activities and provide expert cQA advice and strategic guidance to stakeholders (e.g., Clinical Operations, Data Management, Pharmacovigilance, etc.) based on analysis and interpretation of GCP regulations.
- Design and implement the creation/management/maintenance of quality metrics and plans.
- Collaborate with staff performing quality audits of investigator sites and various clinical vendors.
- Provide cQA oversight for quality reviews of clinical study documents, including, but not limited to investigator brochures, clinical protocols and clinical study reports, case report forms and informed consents forms, etc.
- Accountable for inspection readiness activities, including leading and facilitating agency inspections.
- Participate in relevant study/program team meetings in order to address quality issues that may arise, including identification and resolution.
QUALIFICATIONS AND EXPERIENCE:
- Current and strong working knowledge interpretation/implementation of United States Code of Federal Regulations, ICH Guidelines and other local government regulatory requirements governing clinical research.
- Ability to lead cross-functional teams and independently prioritize work, manage multiple projects while maintaining quality and being an advocate for regulatory compliance.
- Ability to use expertise and skills to contribute to the development of company objectives and principles, and to achieve goals in creative and effective ways
- Travel may be required between 15 and 30% of the time
- Auditor certifications a plus
- 20+ years of progressive global quality / regulatory compliance background in pharma/biotech and medical device industries, with a hands-on role in quality operations and quality systems preferred.
- Thorough understanding of GCP ICH Guidance requirements and related GCP regulations
- B.S./M.S. in relevant science field
Vir's compensation and benefits are aligned with the current market and commensurate with the person's experience and qualifications. All full-time employees receive a package that includes: compensation, bonus and equity as well as many other Vir benefits and perks such as: health, dental, vision, life and disability insurance benefits, non-accrual paid time off, one Friday a month paid-time off, company shut down for holidays, commuter benefits, child care reimbursement, education reimbursement, 401K match and lunch for all lab essential personnel!
Vir is an equal opportunity employer. We value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform critical job functions, and to receive other benefits and privileges of employment. Please contact Human Resources to request accommodation.
Vir Human Resources leads recruitment and employment 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. We ask that external recruiters and/or agencies not contact or present candidates directly to our hiring manager or employees.