Reporting to the Head of Quality Assurance, will play a pivotal role in ensuring the highest standards of professional excellence, regulatory adherence and quality within the business, with overall responsibility and accountability of the site Quality Management System. Working closely with senior leaders in all areas of the business, this position will play an integral role in the development of the local QMS strategy/business planning, aligned closely with the global QA function.
Essential Duties and Responsibilities
- Key member of the QA leadership team. The incumbent will play an integral role in the strategy and business planning processes, ensuring cross functional collaboration and leadership execution for the site Quality Management System, inclusive of GMP standards, compliance programs and as the owner of our QA GMP system
- Ideally act as site QP with responsibility of overseeing the local GMP manufacturing protocol and the release of manufactured drug substance to clients per QAA or release finished products to the EU market
- A key element of the role as part of the site startup will include the establishment of our WuXi Biologics quality system and the associated leadership cascade across all functional areas.
- This role will also participate in global QMS projects and ensure global implementation and delivery aligned with regulatory and client expectations.
- A key element of this role will be the establishment of the QMS function including the associated framework and structure for management of Quality related documentation.
- This role will be accountable to review and approve all QMS related documents and manufacturing generated documents, including but not limited to: SOPs, batch records, deviations, CAPA, change control, QRM, etc.
- This role will be greatly involved in the site self-inspection program establishing an auditing program for each functional area while ensuring all quality related process are in full compliance to all regulatory, market, EU, FDA and company standards.
- This role will be responsible for preparation of regulatory submissions and inspection readiness.
- Develop/build a world-class Biologics QMS team, including planning, recruiting/hiring, coaching/mentoring, and training in QA for QMS, Risk Assessment, Compliance, and GMP e-system.
- Lead the periodic management review and annual product process review/CPV.
- Lead the Qualification of the CMO/CRO.