Job Title: QC Manager (Day Shift)
Location: Cambridge, ON (In-Office)
Position Type: Full-time regular

Shift: Day Shift, Monday - Friday
Vacancy Status: This role is currently vacant
AI Disclosure in Hiring: We do not use artificial intelligence to screen, assess, or select applicants

Job Summary

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.

Key Role Specific Requirements

• 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

Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.

What you bring to the role

• 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;

Competencies Required for the Role

• PLANNING - is the process of thinking about and organizing the activities required to achieve a desired goal.
• THOROUGHNESS/DETAIL ORIENTED - Ensuring that one's own and others' work ad information are complete and accurate; carefully preparing for meetings and presentations following up with others to ensure that agreements and commitments have been fulfilled.
• DECISIVENESS
  - The ability to make difficult decisions in a timely manner and avoid procrastinating or asking for unnecessary data or information.
• CUSTOMER ORIENTATION - The ability to demonstrate concern for satisfying one's external or internal customers. Identifies and prioritizes customer needs and recognizes constraints. Seeks to find out more about customers and provide better service. Is professional, reliable and delivers on promises. Brings a competitive focus to customer.
• EFFECTIVE COMMUNICATION - Is the ability to convey information to another effectively and efficiently, to listen - help facilitate sharing of information between people. It is about understanding the emotional intention behind the information. The ability to express oneself clearly in conversations, confirm understanding, communicate using data and facts. Exhibit willingness to listen, and show respect for oneself and others in interactions with others. express oneself clearly in verbal and business writing.

Compensation & Benefits:

• Competitive salary.
• 13 paid holidays.
• Competitive vacation policy effective upon hire.
• 5 paid personal care days.
• Employee Assistance Program.
• Expected Salary Range: $95,000- $125,000 /Year, DOE