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 Clinical Quality Assurance (cQA) Associate Director to support the company's Clinical Quality Assurance program. This role will assist in the development and improve the existing Good Clinical Practice (GCP) related quality systems to ensure clinical trials are conducted with the appropriate regulations, guidelines, procedures and protocols. This role is responsible for developing specific internal procedures, training of staff and hosting regulatory inspections, leading global clinical quality operations, and liaison of clinical quality related issues with VIR's functional areas. In this role you will have the ability to execute CQA tasks with minimal; effectively represent QA within a GCP team setting and lead quality related activities at clinical vendors, investigator sites, and regulatory agencies. In addition, the candidate must actively manage an appropriate level of inspection readiness of VIR's clinical stakeholders and act as a catalyst for continuous process improvement.
RESPONSIBILITIES AND LEARNING OPPORTUNITIES:
- Support the development and maintenance of GCP related quality system SOPs to align with existing company policy.
- Ensure clinical trials are performed in study protocols within compliance regulatory requirements.
- Perform quality audits of investigator sites and various clinical vendors; internal audits within compliance system, and quality reviews of clinical study documents, such as investigator brochures, clinical protocols and clinical study reports, case report forms, informed consents forms, and corrective and/or preventive actions (CAPAs).
- Serve as a SME on regulatory and GCP requirements, standards and guidelines to provide CQA advice along with building a cross-functional partnership with Clinical Operations, Data Management, Pharmacovigilance, etc.
- Lead all aspects of cQA departmental with staff, contractors, and clinical vendors. Manage GxP trainings programs to internals and externals partners, as applicable.
- Assist with supervising GCP compliance audit trends, group metrics, reporting, and presenting metrics driven data in relates to GCP deficiencies to upper management.
QUALIFICATIONS AND EXPERIENCE:
- 5 years + experience within global quality / regulatory compliance, quality operations background within pharma/biotech, or medical device industries.
- B.S./M.S. in relevant science field.
- Proven understanding of interpretation/implementation of United States Code of Federal Regulations, ICH Guidelines and other local government regulatory requirements governing clinical research.
- Global clinical trial oversight preferred
- Travel will be required between 25 to 30% of the time.
- Auditor certifications a plus.
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.