Summary:
The QA Senior Manager is responsible for leading a group of QA specialists focusing on management of deviations, CAPA, laboratory investigations, complaints and change controls. QA Senior Manager is also responsible for managing communications with external stakeholders with regard to the investigation handling and closure.
Responsibilities
- Responsible for ensuring deviations, laboratory investigations and complaints are investigated in a timely manner and thoroughly to determine the root cause(s) and determine appropriate CAPAs with the area owners.
- Provide oversight for the investigation lead training program. Conduct training and assess the participants to certify investigation lead(s).
- Responsible for review and approval of change controls related to batch manufacturing, packaging, testing and release.
- Responsible for managing communications with external stakeholders with regard to investigation handling and closure. This includes both written and verbal communication.
- Collaborate with Quality Compliance, Quality Systems and Shopfloor Quality to meet GMP requirements. This includes participating in continuous improvement projects and supporting audits.
- Manage costs within budget allocated to the team and be involved in budget planning for Quality function.
- Coach team members on both technical and soft skills and work with them on their development plan.
- Ensure inspection readiness and serve as the primary liaison with regulatory inspectors and/or clients during regulatory and customer audits.
Qualifications
- Bachelor's degree or equivalent experience in Pharmacology, Chemistry, Biology, Molecular biology, or Biochemistry
- 8+ years relevant work experience
- Highly organized with excellent attention to detail
