Our client is a leading pharmaceutical and biopharmaceutical organization with a strong global presence and a commitment to delivering high-quality medicines and addressing patients’ needs. The organization fosters a high-performing, inclusive culture that values fresh thinking, collaboration, professional growth, and operational excellence.
Our Team, Your Impact
The Site Quality Head provides strategic and operational leadership for all Quality functions across Manufacturing, Packaging, Importation, and Laboratory Operations. This role is accountable for fostering a strong quality culture, ensuring compliance with regulatory requirements, and maintaining the highest standards of product quality and patient safety.
Key responsibilities include oversight of quality systems and processes, including but not limited to:
- Development, implementation, and execution of quality procedures and standards
- Establishment Licensing compliance
- Quality on the Floor activities, audits, and batch disposition/release
- Management of laboratory investigations, deviations, complaints, and nonconformances
- CAPA development, implementation, and effectiveness monitoring
- Quality metrics, trending, and performance reporting
- Validation program compliance
- Oversight of equipment, facilities, and utility systems to ensure adherence to established quality requirements
The role is responsible for leading the development, standardization, implementation, monitoring, and continuous improvement of Quality Systems, compliance programs, industry best practices, and corporate quality initiatives. The successful candidate will drive proactive quality and compliance improvements while strengthening a culture of operational excellence and Good Manufacturing Practice (GMP) compliance.
This position also serves as the Senior Person In Charge (SPIC) for Controlled Drug Substances and Narcotics.
How You’ll Spend Your Day
- Lead the site's Quality organization, including Quality Assurance, Quality Control, Microbiology, Quality Systems, and Quality Compliance.
- Ensure a robust and continuously improving Quality Management System (QMS) is maintained.
- Ensure products are manufactured, released, and distributed in compliance with cGMP requirements and approved regulatory specifications.
- Serve as the highest-ranking quality authority on site with independent decision-making responsibility regarding product quality and potential market actions.
- Assess, manage, and mitigate quality risks to ensure products are safe, effective, and compliant before reaching patients.
- Partner with business leaders to ensure a reliable and compliant supply of products.
- Develop, implement, and continuously improve the Site Quality Program in collaboration with the Site General Manager and Corporate Quality leadership.
- Oversee the collection, analysis, and communication of quality data and performance metrics to site leadership, Corporate Quality, and key internal and external stakeholders.
- Direct Quality Control laboratory operations, including analytical method transfers, testing, and approval or rejection of raw materials, packaging components, in-process materials, and finished products.
- Champion a sustainable culture of quality by promoting accountability, open communication, continuous improvement, and employee engagement.
- Build and maintain strong partnerships with the site leadership team and cross-functional stakeholders.
- Act as a strategic business partner to Supply Chain, Project Management, R&D, Manufacturing Sciences & Technology (MS&T), and Commercial teams to achieve business objectives and project milestones. Provide leadership and expert support during internal audits, customer inspections, and regulatory inspections.
- Ensure Quality KPIs meet established targets and that CAPA commitments are implemented on time, with effectiveness verified through ongoing monitoring.
- Develop, manage, and oversee the annual Quality Operations budget while optimizing resources and organizational effectiveness.
- Travel approximately 5% within the United States.
Your Skills and Experience
- Canadian university degree, or a degree recognized as equivalent by a Canadian university, in Chemistry, Chemical Engineering, Biology, Pharmacy, or a closely related life sciences discipline. Preferred: Master's degree or equivalent advanced degree in Chemistry, Biology, Pharmacy, or a related scientific field.
- Minimum of 10 years of progressive pharmaceutical manufacturing quality leadership experience.
- Extensive knowledge of cGMP requirements and expectations from major global regulatory authorities, including Health Canada, the U.S. FDA, and the European Medicines Agency (EMA).
- Strong understanding of pharmaceutical manufacturing, packaging, technology transfer, quality systems, and regulatory compliance requirements.
- Comprehensive knowledge of Health Canada, FDA, EU, and ICH regulations and guidelines, as well as Chemistry, Manufacturing, and Controls (CMC) content for regulatory submissions.
- Deep understanding of pharmaceutical production processes, product lifecycle management, equipment qualification, validation programs, and manufacturing technologies.
- Demonstrated experience leading and preparing for regulatory inspections, including GMP and pre-approval inspections conducted by the FDA and Health Canada.
- Proven expertise in Quality Systems management and continuous improvement initiatives.
- Strong leadership track record with experience building, developing, coaching, and inspiring large, high-performing teams.
- Excellent communication, stakeholder management, and strategic leadership capabilities.
This position is being recruited to fill a current vacancy. The organization may use an artificial intelligence (AI) system to assist with the initial screening and evaluation of job applications by analyzing relevant skills, professional experience, and education against the posted job qualifications. All final hiring decisions are made by a member of the hiring team.
Thank you in advance for your interest, only individuals deemed to have the skill set and experience to fit the role will be contacted. Applicants must be legally entitled to work in Canada without sponsorship.
We are equal-opportunity and affirmative action employers that do not discriminate on the basis of race, national origin, religion, age, colour, sex, sexual orientation, gender identity, disability, veteran status, or any other characteristic protected by local, state, provincial, or federal laws, rules, or regulations. Our policy applies to all terms and conditions of employment.
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