The QA Director will provide operational leadership for the Parenteral Facility, and be responsible for quality oversight of all GMP activities, batch disposition, and development, management, and maintenance of all quality systems supporting PF operations.
This leader will ensure compliance to all applicable regulatory requirements and that all GMP activities consistently operate in a state of control to successfully undergo domestic and international regulatory agency scrutiny.
In addition to aseptic expertise, the ideal candidate will also have strong leadership skills, as this role will lead a team of quality associates and be a member of a cross-functional Site Leadership Team.
- Support development of overall strategy and management of highly effective, efficient Quality Systems. Continuously review Biogen procedures and practices to ensure quality standards are compliant with regulatory requirements.
- Management of all domestic and international regulatory agency and strategic partner site inspections. Assures appropriate resolution of inspection/compliance commitments.
- Provide counsel to the Site Operational Leadership team with respect to GMP compliance matters.
- Direct investigations and resolution of all exceptions and ensure that appropriate, timely corrective and preventive actions are implemented and documented.
- Ensure timely review and approval of all Quality Assurance activities including but not limited to batch disposition of production records.
- Assist in implementation of Global Quality Assurance strategic initiatives.
- Develop, monitor and report status of KPI compliance metrics including product release, exceptions, and CAPA identifying adverse trends and potential risk for the organization.
- Lead a team of direct reports. Actively manage team’s workload and provide coaching and development to staff.
20 years related experience; or a graduate degree with 15 years related experience with at least 10 years directly supporting aseptic operations.
Strong leadership with ability to work with senior leaders and ability to lead by influence in a matrix environment.
BS degree in scientific field; graduate degree preferred
Employment CategoryFull-Time Regular