At a Glance
- Tasks: Lead quality operations, audits, and compliance in a fast-paced pharmaceutical environment.
- Company: Dynamic pharmaceutical company based in Montreal with a focus on quality excellence.
- Benefits: Competitive salary, professional development, and opportunities for career advancement.
- Other info: Join a collaborative team dedicated to continuous improvement and innovation.
- Why this job: Make a significant impact on product quality and compliance in the healthcare industry.
- Qualifications: Master’s degree and 10+ years in Quality roles, bilingualism is a plus.
The predicted salary is between 99000 - 121000 $ per year.
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.
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.
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
Director of Quality in Montréal employer: Confidential
As a General Manager in our Projects Group, you will thrive in a dynamic and supportive work culture that prioritizes employee growth and development. Our commitment to excellence is matched by our focus on fostering strong client relationships and delivering high-quality project outcomes across the Americas. With a diverse team of professionals and a multi-office setup, we offer unique opportunities for collaboration and innovation, making us an exceptional employer for those seeking meaningful and rewarding careers.
