Manager – External Quality

Role Overview

• Responsible for quality oversight of Apotex Third Party Finished Product Suppliers
• Ensure all products manufactured for Apotex meet strict regulatory requirements and comply with cGMP
• Act as a representative of Apotex interacting with various levels of management both at Apotex and with External Partners
• Develop strong working relationships and collaborate with Quality personnel to resolve quality related matters
• Perform final reviews and approvals of GxP documents
• Liaise with internal/external quality functions on quality issues relating to third party manufacture
• Act as the primary point of contact with third party organizations on all quality related matters
• Participate in cross-functional new product introduction teams, ensuring quality and compliance are assured at launch and throughout commercialization
• Establish a strong relationship with third party organizations
• Implement quality systems to monitor key quality metrics to enable evaluation of trends and continuous assessment of compliance risks
• Develop and negotiate quality agreements with third party organizations for Manufacturing/Packaging activities and all other activities, as required
• Perform periodic reviews and ensure update of all current Quality Agreements
• Receive and review impact of significant deviations generated by third party manufacturers and concur action steps, as required
• Initiate and drive through to resolution the Apotex ‘Critical Incident Management’ process for notification of significant quality incidents associated with third party operations
• Review and approve third party manufacturer’s Stability, Process Validation and Analytical Validation protocols and Summary Reports
• Review and approve third party manufacturer’s Change Controls
• Provide oversight of third party manufacturer’s investigations into Customer Complaints, Quality Incidents and Deviations to ensure root causes are identified and effective CAPAs are developed and implemented
• Review Annual Product Reviews issued by third party manufacturers, along with Apotex sections of responsibility, and ensure recommendations are implemented in a timely manner
• Facilitate the Apotex External Audit process at key third party manufacturers
• Define appropriate action plans for improvement and periodically follow up and communicate action item closures
• Follow up with Third Party Organizations to obtain current GMP evidence to support Regulatory Compliance status
• Implement and apply a risk–based approach to third party manufacturing operations quality oversight and seek efficiencies in operations without compromising product quality
• Promote continuous improvement activities
• Perform all work in support of our Corporate Values
• Operate in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements

Requirements

• Minimum 10 years experience in the pharmaceutical industry with relevant QA/QC/Mfg experience, preferably with multiple dosage forms
• Minimum B.Sc. in Biology, Microbiology, Chemistry, Pharmacy or a related science
• Excellent understanding of Canadian and US Good Manufacturing Practices
• Demonstrated, process-driven, analytical, and critical thinking skills
• Ability to effectively manage multiple projects at the same time
• Strong organizational, interpersonal and communication skills
• Strong relationship management skills

Benefits

• Apotex is committed to fostering a welcoming and accessible work environment
• Accommodation for applicants with disabilities as part of its recruitment process