Associate Director – Quality

Isologic Innovative Radiopharmaceuticals (Isologic); Montreal (administrative region); On-site; CAD 130,000 - 170,000; Full time

Job summary

ISOLOGIC Innovative Radiopharmaceuticals seeks an Associate Director – Quality to lead the Quality function for our Lachine PET manufacturing operations. You will ensure GMP compliance, support regulatory inspections, and drive the Pharmaceutical Quality System (PQS) across sites.

You will mentor QA staff, manage batch disposition, and collaborate with Operations, Regulatory Affairs, and Engineering to uphold patient safety and product quality in a fast-paced environment.

Qualifications

• Bachelor's degree in a relevant scientific discipline.
• Minimum 10 years of Quality Assurance experience in pharmaceutical or radiopharmaceutical industry.
• Minimum 5 years of supervisory or leadership experience.
• Strong knowledge of Health Canada, FDA, ICH, and GMP requirements.
• Knowledge of CNSC and TDG regulations; experience with radioactive materials is assets.
• Experience with pharmaceutical QMS/PQS, GMP/cGMP, and GLP preferred.
• Strong knowledge of investigations, CAPA, deviations, OOS, change control, risk management, audits, and inspection readiness.
• Excellent written and verbal communication and technical writing skills.
• French proficiency (spoken and written); English for regulatory guidance.
• Background in Nuclear Medicine Technology or Radiopharmaceutical Sciences is an asset.

Responsibilities

• Provide strategic and operational leadership for the Quality Assurance function at the Lachine PET manufacturing facility.
• Lead QA personnel and oversee product quality and batch disposition.
• Support regulatory inspections and drive continuous improvement.
• Collaborate with cross-functional teams to ensure safe, compliant radiopharmaceutical manufacture.
• Maintain PQS effectiveness and ensure CAPA, investigations, and deviations are addressed.
• Oversee Environmental Monitoring, Sterility Assurance, and documentation practices.

Skills

Quality Assurance

Regulatory Compliance

GMP

CAPA & Investigations

Leadership

Documentation & SOPs

Quality Systems

Risk Management

Cross-functional Collaboration

Communication

Education

Bachelor's degree in Chemistry, Biology, Microbiology, Pharmacy, or related

Tools

QMS/PQS

GMP/cGMP

GLP

ICH Q10

Job description

ISOLOGIC Innovative Radiopharmaceuticals offers an exceptional opportunity to join our dynamic team as an Associate Director – Quality. If you are passionate about nuclear medicine, quality, and patient safety and want to make a meaningful contribution in a stimulating and fast-paced environment, this opportunity is for you.

ISOLOGIC is seeking an Associate Director – Quality to provide strategic and operational leadership for the Quality function supporting our Lachine PET radiopharmaceutical manufacturing operations. This role is responsible for ensuring compliance with GMP regulations, Health Canada requirements, corporate quality standards, and effective operation of the Pharmaceutical Quality System (PQS).

The Associate Director – Quality will lead Quality personnel, oversee product quality and batch disposition, support regulatory inspections, drive continuous improvement, and collaborate with cross-functional teams to ensure the safe, compliant, and reliable manufacture of radiopharmaceutical products.

Key Duties & Responsibilities

Leadership & People Management

• Provide strategic and operational leadership for the Quality Assurance function at the Lachine PET manufacturing facility.
• Promote a culture of quality, GMP compliance, accountability, and continuous improvement.
• Mentor, coach, and develop QA Coordinators in GMP and regulatory compliance.
• Establish departmental objectives and monitor performance.
• Manage the Quality training program and support competency development.
• Support recruitment, onboarding, and development of Quality personnel.
• Represent Quality on cross-functional teams and strategic projects.
• Collaborate with Operations, Manufacturing, Regulatory Affairs, Engineering, CMC, Radiation Safety, EHS, and other functions.
• Travel to other ISOLOGIC sites when required.

GMP Operations & Product Quality

• Provide Quality oversight of daily manufacturing operations to ensure GMP compliance.
• Support timely batch review, documentation review, and product release activities.
• Liaise with Operations to ensure quality and regulatory requirements are consistently met.
• Provide Quality support to CMC and operational functions.
• Lead and maintain Environmental Monitoring and Sterility Assurance programs.

Compliance & Regulatory Oversight

• Lead internal audits, support external audits, and coordinate regulatory inspections.
• Host regulatory inspections and develop responses and corrective action plans.
• Monitor CAPA implementation and effectiveness following inspections and audits.
• Support pharmacovigilance activities, including customer complaints and adverse event reporting.
• Identify, assess, and elevate Quality and Compliance concerns and initiate appropriate actions.
• Maintain a high state of inspection readiness.

Quality Systems & Continuous Improvement

• Own and maintain the effectiveness of the Lachine PQS in accordance with Health Canada GMP, corporate requirements, and ICH Q10.
• Lead investigations related to deviations, OOS results, non-conformances, and other quality events.
• Ensure effective root cause analysis and CAPA implementation.
• Review and approve Quality documentation and ensure Good Documentation Practices.
• Develop, review, and support SOPs and quality processes.
• Monitor QMS performance and Quality KPIs, identify trends, and implement improvements.
• Support change management, validation, process improvement, and operational excellence initiatives.
• Apply risk-based decision-making and ensure ICH Q9 principles are incorporated into Quality and manufacturing activities.
• Drive standardization and harmonization of Quality processes across ISOLOGIC sites.

Qualifications & Required Skills

• Bachelor's degree in Chemistry, Biology, Microbiology, Pharmacy, or another relevant scientific or technical discipline, or equivalent.
• Minimum 10 years of Quality Assurance experience in the pharmaceutical or radiopharmaceutical industry.
• Minimum 5 years of supervisory or leadership experience.
• Strong knowledge of Health Canada, FDA, ICH, and GMP requirements.
• Knowledge of CNSC and TDG regulations and experience with radioactive materials are assets.
• Experience with pharmaceutical QMS/PQS, GMP/cGMP, and GLP is preferred.
• Strong knowledge of investigations, CAPA, deviations, OOS, change control, risk management, audits, and inspection readiness.
• Excellent written and verbal communication and technical writing skills.
• Strong analytical, organizational, problem-solving, and decision-making skills.
• Ability to work independently and collaboratively in a fast-paced environment.
• Ability to accommodate shift changes based on business needs.
• French proficiency (spoken and written) is required to review QA documentation and communicate with site personnel. English proficiency is required to interpret regulatory guidance and support corporate reporting.
• Background or practical experience in Nuclear Medicine Technology or Radiopharmaceutical Sciences is an asset.
• Strong interpersonal skills and ability to work effectively with diverse teams.

Join ISOLOGIC

Join the ISOLOGIC team and contribute to our mission of saving lives through innovative nuclear medicine solutions. We offer a dynamic, collaborative, and continuously improving environment where your expertise and leadership can make a meaningful impact on product quality, regulatory compliance, and patient care.