About the role:
Reporting to the Director of Quality Affairs, Canada, the Senior Quality Control Manager directs and manages the Quality Control laboratory and the Microbiology laboratory to ensure lab testing provides the highest quality analytical support for manufacturing while ensuring compliance with protocols, cGMP and safety regulations. This position will also establish performance standards, procedures and audit controls in order to meet business requirements, as well as Identify and implement process improvements to increase the efficiency, effectiveness, and quality of company operations. This position manages the performance of 6 direct reports; QC Supervisor (2), QC Project Lead, Microbiology Supervisor, Stability Chemist and Raw Material Coordinator.
What you'll do:
- Directs and prioritizes the Quality Control and Microbiology laboratories 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 and Microbiology 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 and Microbiology 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;
- Evaluates and decides upon corrective actions to be taken in response to excursions in controlled environmental conditions to which products are exposed so that product sterility assurance is maintained.
- Acts as a subject matter expert for laboratory investigations, deviations, and CAPA.
- 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
- Other duties as assigned
What you bring to the role:
- Ten years’ relevant experience in a regulated Pharmaceutical industry including Microbiology, Quality Control, with 5 years in a leadership role;
- BSc degree in science or related field;
- Knowledge of Analytical Chemistry, cGMP, Quality Systems, Drug Regulatory Affairs, Stability protocols and systems, manufacturing and packaging processes;
- Must possess apparent leadership qualities to be able to comfortably and successfully interface and communicate with all levels internally and externally;
What We Offer:
- Competitive Salary
- Paid Holidays
- Competitive Vacation Policy
- Paid Sick Days
- Medical, Dental, Vision Insurance
- Pension plan
- Employee Assistance Program
At Bimeda we are committed to fostering an inclusive, barrier-free and accessible environment. Part of this commitment includes arranging accommodations to ensure an equitable opportunity to participate in the recruitment and selection process. If you require an accommodation, we will work with you to meet your needs.