Our client is seeking a highly skilled and experienced Quality Assurance Manager (QA) to oversee the release of new pharmaceutical products into the Canadian market, ensuring compliance with Health Canada regulations. This role involves working with a variety of pharmaceuticals, including nutraceuticals, over-the-counter, and prescription medications. The successful candidate will lead a team of four Quality specialists, ensuring that all products meet quality standards and regulatory requirements. Additionally, the QA Manager will be responsible for relaunching products as necessary to maintain compliance and meet market demands.
Key Responsibilities:
Quality Management: Oversee all aspects of QA operations, including sampling, testing, and analysis of pharmaceutical products to ensure compliance with Health Canada regulations and industry standards.
Team Leadership: Manage and mentor a team of four quality specialists, providing guidance, training, and support to ensure optimal performance and professional development.
Regulatory Compliance: Stay abreast of relevant regulations and guidelines set forth by Health Canada and other regulatory bodies, ensuring that all quality control processes and procedures adhere to these standards.
Product Release: Coordinate the timely release of new pharmaceutical products into the Canadian market, conducting thorough reviews and assessments to verify compliance with regulatory requirements.
Product Relaunch: Develop and implement strategies for relaunching products, including conducting investigations, implementing corrective actions, and ensuring that all relaunched products meet quality and regulatory standards.
Documentation and Reporting: Maintain accurate and comprehensive documentation of all quality activities, including test results, procedures, and protocols. Generate regular reports to communicate key findings and performance metrics to senior management.
Cross-functional Collaboration: Collaborate with cross-functional teams, including manufacturing, regulatory affairs, and research and development, to ensure alignment and integration of quality control processes with overall business objectives.
Continuous Improvement: Identify opportunities for process improvements and efficiency gains within the quality control function, implementing best practices and innovative solutions to enhance overall quality and productivity.
Compliance Audits: Assist with internal and external audits of quality control systems and procedures, addressing any findings or deficiencies and implementing corrective actions as needed.
Qualifications:
· Degree in life sciences, pharmacy, or a related field. B.Sc. considered. M.Sc. or PhD preferred.
· 5 to 10 years of relevant experience in quality within the Canadian pharmaceutical industry.
· Strong knowledge of Health Canada regulations and guidelines pertaining to pharmaceutical, nutraceutical, OTC importation, repackaging, and sale in Canada.
· Proven leadership experience, with the ability to effectively manage and develop a team of QA specialists.
· Excellent analytical and problem-solving skills, with a keen attention to detail.
· Strong communication and interpersonal skills, with the ability to collaborate effectively across functional areas and levels of the organization.
· Demonstrated ability to thrive in a fast-paced, dynamic environment, with a commitment to continuous learning and professional development.
· Excellent English communication skills.
Job Type: Full-time
Benefits:
- Casual dress
- Company events
- Dental care
- Disability insurance
- Employee assistance program
- Extended health care
- Flexible schedule
- Life insurance
- On-site parking
- Paid time off
- Relocation assistance
- Vision care
Flexible language requirement:
Schedule:
Ability to commute/relocate:
- Ottawa, ON: reliably commute or be willing to relocate with an employer-provided relocation package (required)
Education:
- Bachelor's Degree (required)
Experience:
- quality assurance: 5 years (required)
- health canada interaction: 5 years (required)
Language:
Work Location: In person
