- Manages a 24/7 Quality Control operations, consisting of 6 QC supervisors and a total of approx. 40 employees.
- Ensures that all materials and products that require testing and release in the laboratory are done so according to agreed specifications and procedures in a cGMP environment.
- Manages an effective QC documentation system. The QC Manager will prepare, review, and approve documents as required.
- Responsible for monitoring, statistically analyzing, trending, and reporting of QC data/metrics to evaluate performance and risks
- Actively engages with the Laboratory management teams to implement and maintain a system for capacity planning and demand forecasts.
- Compile's data and develop analysis to support QC Investigations, KPIs and other QC Reports as requested. Develop and manage the department budget and capital expenditure budget
- Represents QC matters during regulatory agency and customer inspections.
- Implement and manage a structured business process to ensure all QC work (standard/non-standard) is captured and up to date.
- Ensures laboratory documentation and computerized systems comply with data integrity policies and regulatory requirements.
- Manages laboratory resources (instruments and personnel) to provide a comprehensive analytical service for testing of all QC and microbiological samples.
- Leads the QC workstream of technology transfer as part of the CDMO business assuring the milestones of the projects are reached.
- Manages the investigation into any non-conformance, instrument malfunction, accident, or other abnormal occurrence. Ensure that any Out of Specification (OOS) or Out of Trend (OOT) analytical results are managed as per standard operating procedures (SOP).
- Pharmaceutical quality control operations experience in CDMO business
- 8+ years of applicable experience - cGMP pharmaceutical quality control operations experience with people management experience)
- Knowledge of Good Manufacturing Practices for pharmaceutical manufacturing (21 CFR 210, 211 and 820) and ICHQ7 Good Manufacturing Practice Guidance for APIs.
- Knowledge in 21 CFR Part 11 and Data Integrity Guidelines for pharmaceutical manufacturing
- Bachelor's degree in Chemistry, Chemistry Engineering, Pharmacy, Biochemistry, Biology or a related science.