Our client is a leading pharmaceutical company that specializes in dermatological treatments with a mission to advance dermatology through innovation and manufacturing. They are looking for a Senior Manager for Quality Assurance in the GTA.
- Lead Quality Assurance within Canada, ensuring GMP, industry, corporate, and regulatory compliance.
- Oversee and manage activities within Quality Assurance team.
- Ensure company products comply with GMP, GDP, customer, company, and government expectations.
- Achieve Quality Assurance operational objectives
- Ensure best practice of Quality Compliance and Management between manufacturing sites and Canadian Affiliates.
- Lead inspection-readiness program.
- Be up to date on current compliance regulations and initiatives.
- Provides and directs remediations of nonconformances.
- Ensures nonconformance investigations lead to CAPA and prevention reoccurrence.
- Leads post market surveillance activities.
- Ensure quality management systems and subsystems meet regulatory, customer, and company requirements.
- Maintains DEL, SL, MDEL, and other licence establishments.
- Maintains GxP systems to comply with global Health Canada requirements.
- Leads all GxP system implementation throughout entire cycle.
- Other duties as assigned.
- Bachelor’s degree required (Sciences preferred)
- 5+ years of experience in leadership/management role in a GMP environment
- 10+ years of experience in manufacturing and laboratory processes of Prescriptions, Biologics, Over The Counter (OTC), Medical Device, Natural Health Products (NHP) industries.
- Additional graduate certificate in pharmaceutical field is preferred
- Experience with auditing (with auditing certification preferred)
- Strong knowledge of HPFBI, GM and guidelines
- Experience in pharmaceutical risk management
- Basic knowledge of MS Software and computer/software operations
- Ability to work cross-functionally and autonomously
To apply, please submit your resume using the Apply Now button.
We thank all interested applicants, however, only the candidates chosen for an interview will be contacted.