Quality Assurance Manager
Working as a partner with Operations, QC, EMU, Planning and STS the Building A Suite AB Quality Manager is accountable for all activities required to disposition product and ensure overall compliance of all processes included in the Suite A/B Asset. Additionally, is accountable for the assurance that all activities related to processing, and disposition for the product(s) is/are in full compliance with government regulations and internal company standards and values. Strong communications skills are needed to be successful in this role
- Leads the efforts of QA personnel responsible for the monitoring, testing, and disposition of the product in compliance with all regulatory requirements, company policies, values, and goals
- Responsible for quality record review such as investigations, CAPAs, Change Controls.
- Partners with other QA managers to ensure consistency and efficiency within the QA department.
- This position requires strong collaboration skills, working with the network and Prevnar product team to ensure supply of Poly.
- Decision maker for compliance and quality issues and documentation such as investigations, protocols, change controls, regulatory filings, etc.
- Responsible to the asset for GMP compliance of the Suite AB manufacturing facility as well QA shift support for all assets
- Participates in the recruitment, selection, promotion, termination, and performance management of QA employees
- Partners with the Asset Team (Operations, Engineering, Technical Services and Supply Chain) to provide feedback on performance of non-Quality personnel.
- Partners with the Asset Team for cross-functional management staff to evaluate production process needs, resolve problems and obstacles, provide resources. Reset direction and maximize effective interactions and functioning using IMEX to drive performance
- BS or BA degree (Chemistry, Engineering, Biology, Manufacturing Management)
- 12 plus years experience in pharma/biopharma industry, 5+ years management experience
- Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
- Experience in QA and/or Manufacturing and/QC, experience dealing with Regulatory compliance. Experience in problem solving, process improvement, negotiations and supervision
- Ability to gown and enter the manufacturing Suite as needed
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- 24/7 support of manufacturing as quality issues arise
- Some travel may be required but expected to be minimal.