Director, Quality Assurance Systems and Compliance

 Vir Biotechnology - Company site
 August 4, 2022
 United States- REMOTE
Vir Biotechnology is a commercial-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. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus. For more information, please visit www.vir.bio.
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. 
The Director of Quality Assurance will lead the company’s Quality Assurance Systems and Compliance team and will be responsible for process ownership of key compliance systems within Quality including but not limited to Deviations, CAPA, Change Control, Risk Management and Vendor Management.  This role is a key enabler for driving development, implementation, improvement, and effectiveness of the Quality Management Systems (QMS).  The candidate will partner closely with other Quality counterparts and system owners to develop core groups of SMEs from across functional Quality teams, ensuring the overall health of the Quality Management System (QMS). 

RESPONSIBILITIES AND LEARNING OPPORTUNITIES

  • Responsible for implementing and maintaining an efficient Quality Management System (QMS) which reflects the vision, mission, and expectations of the company and meets applicable regulatory body requirements.
  • Implement service provider management programs for a diverse range of vendors, to ensure adherence to regulatory requirements, compliance with QMS and feasibility to execute on business requirements.
  • Utilize technical/professional knowledge and skills to establish, interpret, and appropriately execute company policies and applicable regulations and requirements.
  • Establish and manage governance and oversight mechanisms across the business unit to enable reporting of quality performance to functional areas and leadership. This includes quarterly management review, monthly quality metric reporting, establishment of formal quality improvement plans and other effectiveness reporting as appropriate.
  • Provide decisions and recommendations to senior staff regarding quality related issues.
  • Develop and maintain key performance indicators to measure effectiveness of the Quality Management System.
  • Manage internal and vendor audit programs
  • Establish and manage the Risk Management program
  • Perform Regulatory Compliance Surveillance
  • Manage Inspection Readiness and Inspection Management
  • Demonstrates effective change leadership by building strategic partnerships across functional areas to further departmental and organizational objectives.
  • QUALIFICATIONS AND EXPERIENCE

  • B.S./M.S. and 15+ years or PhD and 10+ years of global quality and regulatory compliance background within pharma/biotech/medical device industries within quality operations and quality systems preferred.
  • Practical knowledge of GxPs and an ability to apply sound judgment and decision-making skills (risk based and appropriate for the phase of clinical development) in order to evaluate product release.
  • Working knowledge of US and EU GxP regulations and guidelines.
  • Ability to lead cross-functional teams, manage multiple projects while maintaining quality and being an advocate for regulatory compliance.
  • Has expertise and experienced skills to contribute to the development of company objectives, and to achieve goals in creative and effective ways.
  • Willingness to travel approximately 20 to 30%
  • This role may be performed remotely if VIR can support remote work arrangements in the state where you currently reside. This includes most states within the US.  If you move forward in the hiring process, VIR recruiters will discuss options with you.
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    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, 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.