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Added 12 mins ago
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Lock Search Group

Senior Director / Site Quality Head - Canada

Toronto, ON, Canada
Greater Toronto Area, Canada, Canada

Job type: Full-time
Apply by: Oct 24, 2026
Experience: Minimum of 10 years of progressive pharmaceutical manufacturing quality leadership experience.
Posting language: English
Posted: Sep 24, 2026

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Original job description

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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More about this job

Responsibilities

Lead the site's Quality organization and maintain an effective Quality Management System, ensuring manufacturing, testing, release, and distribution comply with applicable GMP and regulatory requirements. Direct quality operations, inspections, risk management, CAPA, performance reporting, and budget oversight while partnering with site and corporate leaders to strengthen quality culture and ensure reliable product supply.

Requirements

Requires a Canadian-recognized university degree in a relevant life sciences discipline and at least 10 years of progressive pharmaceutical manufacturing quality leadership experience; a master's or equivalent advanced degree is preferred. Candidates should have extensive knowledge of cGMP and Health Canada, FDA, EU, and ICH requirements, inspection leadership experience, strong quality systems expertise, and a record of developing high-performing teams.

Skills

Pharmaceutical Quality Leadership
Quality Assurance
Quality Control
Quality Management Systems
Current Good Manufacturing Practice Compliance
Regulatory Compliance
Regulatory Inspection Readiness
Quality Risk Management
Corrective and Preventive Actions
Validation and Equipment Qualification
Laboratory Operations
Batch Disposition and Product Release
Quality Metrics and Trending
Team Leadership and Development
Stakeholder Management
Continuous Improvement

Visa sponsorship

Not detected in the job text

Keywords

Pharmaceutical Manufacturing
Biopharmaceuticals
Quality Assurance
Quality Control
Microbiology
Quality Management System
Current Good Manufacturing Practice
Health Canada
U.S. FDA
European Medicines Agency
ICH Guidelines
Chemistry, Manufacturing, and Controls
Regulatory Inspections
Pre-Approval Inspections
Quality Risk Management
Corrective and Preventive Actions
Batch Disposition
Product Release
Laboratory Investigations
Analytical Method Transfer
Validation Programs
Equipment Qualification
Technology Transfer
Quality Metrics
Quality on the Floor
Controlled Drug Substances
Narcotics
Site Quality Program
Manufacturing Sciences and Technology
Supply Chain

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