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About the role
- Corporate Compliance Manager overseeing GMP compliance, product recalls, inspections, and regulatory communications. Supporting Apotex, a Canadian pharmaceutical company providing affordable medicines and health products.
Responsibilities
- Execute critical incident escalations and market action programs
- Interface with regulators and liaise with business stakeholders to support quality and compliance teams
- Provide compliance oversight and support during regulatory inspections
- Review and develop global regulatory authority communications
- Perform industry trend analysis
- Develop and maintain relationships with regulatory agencies, business partners, internal stakeholders, ministries of health, global affiliates, and customers
- Manage notifications and communications concerning potential product defects
- Support regulatory notification and product recall systems
- Develop and implement business processes, controls, and SOPs
- Prepare for post-market inspections and audits
- Represent Corporate Quality & Compliance during inspections
- Provide recommendations and regulatory guidance to senior management and stakeholders
- Evaluate regulatory trends and report risks to Apotex
- Ensure adherence to organizational compliance, quality, safety, environmental, and HR policies
Requirements
- B.Sc. in Chemistry, Biochemistry or a related science
- Minimum 8-10 years of experience in the GMP Regulated industry
- Thorough knowledge of GMPs relative to Health Canada, FDA and other global pharmaceutical regulations
- Clear and concise written and verbal English communication
- Strong organizational, interpersonal and communication skills
- Ability to work under pressure in an international and multicultural matrix organization
- Flexibility in response to a changing and evolving environment; deadline oriented
- Business acumen in understanding cross-functional processes, requirements, and relevant information flows, and translating gaps into solutions
- Strategic, process-driven, analytical, and critical thinking
- Experience holding people accountable, developing cross-functional teams, and facilitating decision-making processes
- Knowledge of SAP, TrackWise, Excel, Word, and other Microsoft Office programs
Benefits
- Bonus programs based on position in the organization
- Pay-for-performance philosophy
- Comprehensive benefits
- Pension plan
- Learning and development opportunities
- Accommodation for applicants with disabilities as part of the recruitment process
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