Director of Quality

Confidential; Montreal; In loco; CAD 110.000 - 140.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical firm in Montreal is seeking a Director of Quality Services. The role encompasses overseeing internal and external quality operations, ensuring compliance with regulations, and leading quality audits. The ideal candidate has a Master's degree and over 10 years of experience in quality roles within the pharmaceutical industry. The position offers full-time employment and requires strong leadership and communication skills.

Competenze

• 10+ years of experience in Quality roles within the pharmaceutical or biopharmaceutical industry.
• Expert knowledge of applicable standards and regulations (e.g., cGMP, ISO 13485).
• Advanced technical and quality expertise in pharmaceuticals.

Mansioni

• Ensure the company maintains valid Establishment Licenses for pharmaceuticals, medical devices, controlled substances, and narcotics.
• Develop and implement a comprehensive quality system across the organization.
• Lead and manage quality audit processes.
• Oversee product release activities.
• Drive development and continuous improvement of quality systems.
• Identify and assess current and potential quality risks.
• Manage controlled documents and ensure regulatory compliance.
• Oversee documentation for change requests, deviations, and CAPAs.
• Manage stability protocols and reports.
• Lead the quality team during technical transfers.
• Oversee the recall process and provide compliance analysis.
• Manage the Quality Services department, including staffing and development.
• Liaise with third-party manufacturers and regulatory authorities.
• Provide quality assessments for Business Development initiatives.
• Continuously seek opportunities to improve processes and team performance.

Conoscenze

Bilingualism (French and English)

Strong verbal and written communication skills

Excellent attention to detail

Strong interpersonal skills and adaptability

Ability to manage multiple priorities in a fast-paced environment

Strong organizational and leadership abilities

Formazione

Master’s degree in a scientific discipline

Descrizione del lavoro

The company and the role is based in Montreal, Quebec, Canada.

About the role

The Director Quality Services is responsible for overseeing both internal and external quality operations and systems. This includes audits, complaints, training, product release, change control, deviations, and overall compliance. The role ensures alignment with current Good Manufacturing Practices (GMPs) and regulatory requirements.

Key Responsibilities

• Ensure the company maintains valid Establishment Licenses for pharmaceuticals, medical devices, controlled substances, and narcotics. Act as liaison for inspections and conduct supplier audits.
• Develop and implement a comprehensive quality system across the organization, including GMP-ISO training and updates to procedures.
• Lead and manage quality audit processes.
• Oversee product release activities.
• Drive the development, harmonization, and continuous improvement of quality systems and procedures to ensure compliance with cGxP standards.
• Identify and assess current and potential quality risks.
• Manage controlled documents (e.g., SOPs) and ensure regulatory compliance.
• Oversee documentation related to change requests, deviations, CAPAs, complaints, investigations, and Annual Product Quality Reviews (APQR).
• Manage stability protocols and reports.
• Lead the quality team during technical transfers.
• Oversee the recall process and provide senior-level compliance analysis.
• Manage the Quality Services department, including staffing, budgeting, development and skill growth.
• Liaise with third-party manufacturers, Health Canada, and other regulatory authorities.
• Provide quality assessments and due diligence support for Business Development initiatives.
• Continuously seek opportunities to improve processes, outcomes, and team performance.
• Bilingualism (French and English)
• Strong verbal and written communication skills
• Excellent attention to detail
• Strong interpersonal skills and adaptability
• Ability to manage multiple priorities in a fast-paced environment
• Strong organizational and leadership abilities

Qualifications

• Master’s degree in a scientific discipline
• Minimum of 10 years of experience in Quality roles within the pharmaceutical or biopharmaceutical industry
• Expert knowledge of applicable standards and regulations (e.g., cGMP, ISO 13485)
• Advanced technical and quality expertise in pharmaceuticals

Seniority level

• Director

Employment type

• Full-time

Job function

• Quality Assurance and Management

Industries

• Pharmaceutical Manufacturing