Manager,Quality-Investigation & Manufacturing

About Apotex Inc.

Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

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• Reporting to the Service Delivery Lead, GBS Global Quality, will hold responsibility to lead investigations (i.e. root cause analysis for identified non-conformances & associated CAPAs) and perform QA responsible tasks (i.e. detailed impact analysis, review, approval and implementation) for Change Control Records pertaining to updates in the Global Standard Operating Documents & Master Manufacturing/Packaging documents for commercial operations) for Global Quality function.
  
  
• Responsible to maintain consistency through the process, ensure change controls, investigation reports & associated CAPA documents are reviewed, assessed, and approved in a timely & efficient manner, in accordance with business needs. This role will extend support globally for SOD management, training management & audit management, as & when required.

• Develop processes to improve operational performance in Change Control, Investigations, and Quality.
• Support, update, and implement GBS QMS procedures aligning with Global Apotex policies.
• Help Service Delivery implement QMS, driving quality culture and deploying global initiatives.
• Facilitate real-time support for functional owners during regulatory audits at Apotex sites.
• Manage GBS QMS documentation, coordinate SOD reviews, and support corporate GBS audits.
• Represent GBS in Corporate Audits and implement new global quality initiatives and projects.
• Ensure all teams comply with cGMPs, compliance programs, and company policies/procedures.
• Monitor progress against corporate goals using data analysis; proactively resolve bottlenecks.
• Lead projects to achieve goals, resolve document issues, and monitor/report department metrics.
• Lead investigations for Global Quality and Customer Services functions as defined by scope.
• Collaborate with Change Owners, SMEs, and customers to identify root causes and implement fixes.
• Ensure audit readiness via self-inspection; introduce new systems and sign off as QA Responsible.
• Establish and maintain efficient Change Control and QA documentation review processes.
• Independently assess change controls to determine correct path, ensuring compliance to SODs and GMP.
• Manage complex multi-SOD changes and track revisions using business applications with minimal supervision.
• Conduct detailed impact analysis on SOD changes for gaps, cGMP, and cross-document compliance.
• Determine change control need and validate scope/rationale; return to owner if invalid.
• Review change details to align with strategies, ensuring appropriate implementation tasks are assigned.
• Provide Quality System guidance and support to SMEs and owners for Change Control packages.
• Offer technical support for templates, change control, formatting, training, and SOD software.
• Track and monitor documentation activities and due dates to meet cycle time and SLA goals.
• Review new/revised Master Manufacturing & Packaging Records ensuring change control implementation.
• Map business processes, resolve inconsistencies, and provide ongoing SOD support/guidance to customers.
• Coordinate adoption of Global Quality System policies for continuous process improvement/harmonization.
• Liaise across Apotex and affiliates to interpret document requirements and resolve SOD issues.
• Coordinate with SMEs and document owners to efficiently implement global policies/procedures.
• Collaborate with departments to reduce documents and update all related SODs by deadlines.
• Ensure documentation accuracy, integrity, availability, and escalate any unresolved issues.
• Ensure all document processes comply with cGMP, quality policies, and meet high standards.
• Evaluate existing quality documents, identify gaps, recommend remediation, and share best practices.
• Participate in site documentation development/revisions to meet global regulatory requirements.
• Facilitate cross-functional teams to identify and implement site-specific process improvements.
• Develop and manage working relationships with customers/stakeholders to assess needs and manage service.
• Perform all work following the Code of Conduct, ethics, and all legal/regulatory requirements.
• Work safely and collaborate as a team member to achieve all established outcomes.
• Demonstrate organizational Values: Collaboration, Courage, Perseverance, and Passion in behavior.
• Ensure personal adherence to all compliance programs: Ethics, Quality, Safety, and HR policies.
• All other relevant duties as assigned.

Job Requirements:

• Education
  • Master's/bachelor's degree in pharmacy/Scientific/business discipline or similar
    
    
• Knowledge, Skills and Abilities
  • Knowledge on Pharmaceutical Quality Management Systems & regulatory requirements
  • Detail-oriented, accurate, reliable, technically proficient (commensurate with job requirements) & able to apply risk-based decision-making in ambiguous or unprecedented circumstances
  • Excellent organizational, interpersonal skills: team building, communication, presentation, facilitation, problem-solving, decision-making, technical writing, analytical, critical thinking skills
  • Able to manage time effectively, work independently and effectively manage multiple priorities in a fast-paced and changing environment
  • Proficient in the use of Microsoft Office software in a network environment, MS Word, Excel, Access and SAP R/3, SAP, QMS, TrackWise and Livelink/Content Server experience is an asset
  • Demonstrated commitment to customer service, ability to work in partnership with and build strong links to all areas of the business, providing high quality deliverables with strict deadlines
    
    
• Experience
  • Minimum 10 years of experience in Quality or Production in Pharmaceutical/Life science company.
  • Breadth of experience in Investigation, Validation, Quality or Production such that the individual can assess impact of changes, non-conformances & associated CAPAs across all functional areas.
  • Hands-on experience of a document management system is an asset.

At Apotex, we are committed to fostering a welcoming and accessible work environment, where all everyone feels valued, respected, and supported to succeed. 

We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.