Manager - External Quality Assurance

Job Summary

The Manager, External Quality is responsible for quality oversight of Apotex Third Party Finished Product Suppliers.  He/She is responsible to ensure all products manufactured for Apotex are meeting strict regulatory requirements and compliant with cGMP. 

The Manager acts as a representative of Apotex interacting with various levels of management both at Apotex and with External Partners.  He/She must develop strong working relationships and collaborate with Quality personnel to resolve quality related matters, and perform final reviews and approvals of GxP documents.

Job Responsibilities

• Liaises with internal/external quality functions on quality issues relating to third party manufacture. Acts as the primary point of contact with third party organizations on all quality related matters.
• Participates in cross-functional new product introduction teams, ensuring quality and compliance are assured at launch and throughout commercialization. Acts as the point of contact for the transition from R&D Quality to Commercial Quality for co-development and in-licensed activities. 
• Establishes a strong relationship with third party organizations.  Implements quality systems to monitor key quality metrics to enable evaluation of trends and continuous assessment of compliance risks.
• Develops and negotiates quality agreements with third party organizations for new and existing third party operations involving Manufacturing/Packaging activities and all other activities, as required. Performs periodic reviews and ensures update of all current Quality Agreements.
• Receives and reviews impact of significant deviations generated by third party manufacturers and concurs action steps, as required. Initiates and drives through to resolution the Apotex ‘Critical Incident Management’ process for notification of significant quality incidents associated with third party operations.
• Reviews and approves third party manufacturer’s Stability, Process Validation and Analytical Validation protocols and Summary Reports.
• Reviews and approves third party manufacturer’s Change Controls.
• Provides 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.
• Reviews Annual Product Reviews issued by third party manufacturers, along with Apotex sections of responsibility, and ensures recommendations are implemented in a timely manner.
• Facilitates the Apotex External Audit process at key third party manufacturers. Defines appropriate action plans for improvement and periodically follows up and communicates action item closures.
• Follows up with Third Party Organizations to obtain current GMP evidence to support Regulatory Compliance status.
• Implements and applies a risk–based approach to third party manufacturing operations quality oversight and seeks efficiencies in operations without compromising product quality. Promotes continuous improvement activities.
• Performs all work in support of our Corporate Values.
• Performs all work in accordance with all established regulatory and compliance and safety requirements.
• Performs all work in compliance with our Code of Conduct and Business Ethics, and related policies and with the legal and regulatory requirements that apply to our job activities.
• Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.
• Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion.
• All other relevant duties as assigned.

Job Requirements

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