QC Manager

Bimeda Inc.

$95K — $125K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • 5+ years in 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, and Drug Regulatory Affairs

Responsibilities

  • Direct and manage Quality Control lab for timely and accurate testing of materials
  • Develop budgets to maintain departmental functions at minimal costs
  • Ensure vendor compliance with qualification standards
  • Safeguard QC staff through training and adherence to cGMP
  • Lead communication and collaboration with internal and external stakeholders
  • Monitor QC systems and report performance metrics
  • Act as a subject matter expert in laboratory investigations and CAPA

Benefits

  • 13 paid holidays
  • Competitive vacation policy effective upon hire
  • 5 paid personal care days
  • Employee Assistance Program
Full Job Description
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 Assurance Canada, the Quality Control Manager is responsible for the strategic direction, operational excellence, and regulatory compliance of the Quality Control function. This senior leadership role directs and manages the Quality Control laboratory to ensure timely and accurate testing of raw materials, in-process materials, finished products, and stability programs while maintaining compliance with protocols, cGMP requirements, and safety regulations.

The Quality Control Manager provides leadership to a multi-shift laboratory organization through a team of supervisors and coordinators and is accountable for building a high performing, engaged, and compliant workforce. The role establishes departmental objectives, performance standards, procedures, and controls to support business goals, drive continuous improvement initiatives, and ensure inspection readiness. As a key member of the Quality leadership team, this position collaborates closely with Manufacturing, Quality Assurance, Regulatory Affairs, Supply Chain, and external stakeholders to support business objectives while maintaining the highest standards of quality, compliance, and operational excellence.

Key Role Specific Requirements

  • Direct and prioritize Quality Control laboratory activities to provide timely and accurate testing of raw materials, in-process materials, finished products, and stability programs while ensuring compliance with protocols, cGMP requirements, and safety regulations.
  • Provide leadership, coaching, and direction to supervisors and coordinators, fostering a culture of accountability, collaboration, employee engagement, and continuous development.
  • Build and maintain a high-performing team through effective performance management, succession planning, talent development, and employee recognition initiatives.
  • Develop and manage departmental budgets to maintain operational effectiveness while ensuring cost efficiency and compliance with quality standards.
  • Establish departmental goals, performance metrics, and operational priorities aligned with corporate objectives and quality strategies.
  • Monitor laboratory performance, analyze key performance indicators, and provide recommendations to senior management to improve efficiency, effectiveness, and quality outcomes.
  • Identify, lead, and implement continuous improvement and lean laboratory initiatives that enhance operational performance, quality, compliance, and customer service.
  • Ensure the safety of Quality Control personnel through training, policy implementation, cGMP adherence, and active participation in Joint Health and Safety Committee activities, inspections, and corrective actions.
  • Lead investigations related to batch discrepancies, deviations, non-conformances, out-of-specification (OOS) results, and other quality events to evaluate impact on product quality and ensure appropriate corrective and preventive actions.
  • Act as the Quality Control subject matter expert for laboratory investigations, deviations, CAPAs, and quality systems, ensuring timely closure and effective resolution of quality events.
  • Serve as the senior laboratory representative during customer audits, regulatory inspections, and corporate audits, ensuring inspection readiness and timely responses to observations and commitments.
  • Lead organizational and process changes within the Quality Control function, ensuring effective implementation and stakeholder engagement.
  • Develop, review, revise, and approve laboratory Standard Operating Procedures as required.
  • Champion a culture of quality, compliance, safety, and continuous improvement across the Quality Control organization.
  • 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
  • Bachelor of Science degree in Chemistry, Microbiology, Pharmaceutical Sciences, or a related scientific discipline.
  • Minimum 8 years of progressive experience in a regulated pharmaceutical, veterinary pharmaceutical, biologics, or life sciences environment, including Quality Control operations.
  • Minimum 5 years of leadership experience, including experience managing supervisors, team leads, or multiple teams within a GMP-regulated environment.
  • Demonstrated experience leading Quality Control operations, laboratory investigations, quality systems, regulatory inspections, and continuous improvement initiatives.
  • Strong knowledge of Analytical Chemistry, Microbiology, cGMP requirements, Quality Systems, Drug Regulatory Affairs, Stability Programs, and pharmaceutical manufacturing and packaging processes.
  • Proven ability to influence stakeholders, lead change, and drive organizational performance through others.
  • Excellent leadership, communication, decision-making, and problem-solving skills.


Competencies Required for the Role
  • EXECUTION/ACCOUNTABILITY - A willingness to accept responsibility or to account for one's actions. Accountability is when an individual or a department experiences consequences for their performance or actions.
  • 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


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