Director of Quality & Compliance – Pharma

Confidential; Montreal; On-site; CAD 110,000 - 140,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

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

Education

Master’s degree in a scientific discipline

Job description

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.