Description:
The Associate Director, Quality Assurance GMP Operations will oversee the Batch disposition process across the US CDMOs. Responsibilities include day-to day operational quality oversight for internal batch record review operations and QA external manufacturing operations from clinical to commercial stage of product globally.
The role will closely partner with operational stakeholders to lead product disposition activities and resolution. A key expectation is the ability to closely collaborate and build relationships with internal and external stakeholders for advancing quality outcomes and operational excellence.
Key Duties & Responsibilities
- Establishment of quality oversight for internal quality and external CDMO operations for the batch disposition process, across development, launch and commercial manufacturing.
- Manage the day-to-day timely release of finished product to ensure compliance with Regulatory and Vertex cGMP requirements.
- Assure disposition activities across US CDMOs are compliant and consistent.
- Develop, establish, and implement Batch disposition operational Quality and Compliance metrics.
- Act as the batch disposition subject matter expert (SME) in support of regulatory inspections and audits, respond to information requests, adjudicate compliance discussions, and negotiate any required corrective actions.
- Identify and communicate risks and assist with risk mitigation plans as necessary.
- Represent C&G Quality to lead/participate in complex projects and partner with key stakeholders for alignment in strategic and operational planning and delivery of business & financial priorities and goals.
- Participate and lead GxP Cell & Gene Therapy Management Reviews to gain insights regarding efficiency and operational performance across the GXP operations, including identification of opportunities for improvement and associated actions.
- Lead and mentor other team members, support development of organizational capabilities and talent building.
- Manage the department resources with regards to budget and personnel.
- Build strategic relationships with internal and external partners – CDMOs within the Quality organization to ensure Quality issues are raised and addressed, as necessary.
Required Education Level
- Bachelor's degree in a biotech/Lifesciences field.
- Master's degree preferred.