Director of Quality; QA – Quality Assurance​/QC – Quality Control

Director of Quality (QA – Quality Assurance / QC – Quality Control)

The Director of Quality is responsible for establishing, leading, and continuously improving the Quality Assurance (QA) and Quality Control (QC) functions across the organization. This role provides both strategic and operational leadership to ensure regulatory compliance, robust laboratory and quality systems, and a strong, embedded quality culture throughout the business.

Reporting to the COO, the Director of Quality provides leadership to the QA Manager and QC Lab Manager and works cross-functionally with Operations, Regulatory, R&D, and the Leadership Team to support both day-to-day execution and long-term organizational improvement.

This role requires a leader with deep laboratory and quality systems experience, sound regulatory judgment, strong writing and communication skills, and a collaborative, development-focused leadership style.

Salary:
Competitive salary, commensurate with experience

Work Environment:
Flexible – some on-site work required, with the possibility of Work-From-Home options available

A minimum of 40 hours per week with a combination of working in the office, laboratory, and manufacturing environments.

Benefits:
Health & Dental benefits after a successful 90-day probation period

Retirement Plan:
Group RSP with company-matched contributions after a successful 90-day probation period

Career Stability:
Long-term employment with a reputable, industry-leading company

Job Functions &

Key Responsibilities:

Quality Leadership & Culture

• Lead, mentor, and develop the QA and QC teams, fostering a strong quality mindset and culture across the organization.
• Act as a developmental leader who collaborates, coaches, and influences.
• Serve as a key member in strategic planning and continuous improvement initiatives.

Regulatory Compliance & Quality Systems

• Overall accountability for compliance with applicable regulations and standards, including cGMP, Health Canada, FDA, HACCP, and other relevant regulatory frameworks.
• Act as primary quality liaison with Health Canada, FDA, customers, and external auditors during inspections and audits.
• Lead audit readiness, execution, response, and follow‑up for regulatory, customer, and internal audits.

Laboratory & Technical Oversight

• Provide technical oversight and strategic direction to laboratory operations.
• Support and guide laboratory investigations, including OOS/OOT results, deviations and root cause analyses.
• Bring hands‑on understanding of method development, with particular strength in LC‑based methods and impurity analysis.
• Demonstrate knowledge of impurity profiling and analysis in alignment with Health Canada expectations.

Computerized Systems & Validation

• Provide leadership and oversight for computerized systems used in QA/QC and laboratory environments.
• Demonstrate strong knowledge of Computer System Validation (CSV), including 21 CFR Part 11 requirements (data integrity, access controls, passwords, audit trails, archiving, and backups).
• Oversee and/or support validation activities, including:
  • Computer system validation
  • Cleaning validation
  • Process validation

LIMS & Laboratory Software

• Bring experience working with Laboratory Information Management Systems (LIMS), including implementation, optimization, or day‑to‑day use.
• If not a LIMS subject‑matter expert, possesses sufficient knowledge to effectively hire, manage, and guide technical resources responsible for LIMS and lab software systems.

Documentation & Writing

• Ensure high‑quality written documentation across the quality system, including SOPs, validation documentation, investigations, protocols, reports, and regulatory responses.
• Review and approve quality documentation with a strong focus on clarity, compliance, and scientific rigor.

Employment Requirements:

• Undergraduate degree (minimum) in Chemistry, Biochemistry, Pharmaceutical Chemistry, or a closely related discipline.
• 8–12+ years of progressive experience in quality and/or laboratory leadership roles within a regulated industry.
• Demonstrated professional experience working directly in a laboratory setting.
• Strong background spanning both QC and QA functions.
• Experience in highly regulated…