QC Manager

Bimeda•Cambridge, ON

5d•CA$95,000 - CA$115,000•Onsite

About The Position

Reporting to the Director of Quality Affairs, Canada, the Quality Control Manager directs and manages the Quality Control 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 it has 3 supervisors (days, afternoons and NPI) and two coordinators (stability and QC) reporting into the manager. A total of five direct reports

Requirements

5 years’ relevant experience in a regulated Pharmaceutical industry including Quality Control, with 3 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

Responsibilities

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.
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, 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
Other duties as assigned