- Directs and prioritizes the Quality Control laboratory to provide for the timely and accurate testing of raw materials, in-process and finished goods, and stability programs and production processes while ensuring compliance with protocols, cGMP and safety regulations.
- Develops budgets to maintain departmental functions at lowest possible cost consistent with quality and operates within the limits of the budget approved.
- Ensures all vendors have been qualified and adhere to vendor qualification standards with the aim of optimal utilization of testing procedures.
- Ensures safety of QC staff through training, policies and cGMP adherence, and support of the JHSC meetings and inspections.
- Leads by example and proactively communicates and collaborates with internal staff, colleagues, and external stakeholders to drive results.
- Achieves results through direct reports by communicating job expectations & company vision; establishing individual goals in line with corporate/departmental objectives, coaching, reviewing performance results; holding accountable; providing training and skill development opportunities for growth and improved performance.
- Monitors QC systems and advises management team on system performance; publishes metrics regarding performance against set goals and makes recommendations.
- Leads in the investigations regarding batch discrepancies, non-conformances and out-of-specification events to evaluate impact on product quality and ensure corrective action and non-recurrence;
- Acts as a subject matter expert for laboratory investigations, deviations, and CAPA, ensuring timely closer of all quality events.
- Acts as the primary point of contact for laboratory investigations information with internal and external auditors and regulatory inspectors.
- Supports and implements continuous quality improvement and lean laboratory initiatives in accordance with GLP.
- Develops, reviews and revises laboratory Standard Operating Procedures as required.
- Ensures the department is adequately equipped with up to date instrumentation and equipment that is properly calibrated and serviced. Maintains knowledge of state-of-the-art technologies and instrumentation and implements or acquires these as needed.
- 5 years’ relevant experience in a regulated Pharmaceutical industry including Quality Control, with 3 years in a leadership role
- BSc degree in science.
- Knowledge of Analytical Chemistry, cGMP, Quality Systems, Drug Regulatory Affairs, Stability protocols and systems.
- Must possess apparent leadership qualities to be able to comfortably and successfully interface and communicate with all levels internally and externally.
- MS degree or MBA as asset