Manager,Quality-Investigation & Manufacturing

Job Summary

• 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.

Job Responsibilities

• 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

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.