Quality Assurance Manager - GMP

Reporting Line: Director, Quality Assurance
                                               

Location: Victoria, B.C. or home-based position West Coast preferred

Purpose of Position

The incumbent will oversee the development, implementation and maintenance of quality assurance systems and activities. Oversees generation and review of documents used in good manufacturing practices (GMP). Maintains oversight of all vendors and will complete audits as directed.   Works with the Chemistry Manufacturing and Control (CMC) team to prepare manufacturing documentation (module 3) for. Coordinates interdepartmental activities.  May lead investigations and resolve potential product quality issues to ensure all manufactured products are suitable for use.

Roles & Responsibilities:

  • Leads all departments to ensure Aurinia and its vendors are in a state of Inspection Readiness, particularly as related to activities associated with Pre-Approval Inspections.
  • Reviews, approves, and manages all Vendor change controls, deviations, and investigations after discussing with the relevant Aurinia departments.  
  • Prepares and reviews Quality Assurance departmental procedures and policy documents when required.
  • Reviews Master Batch Records (MBR), specifications, SOPs, forms, analytical methods and associated validation/transfer documents
  • Reviews completed batch records and releases material for clinical or commercial use.  Liaise with QP for EU release.  
  • Conducts or serves as a lead/coordinator of investigations and corrective and preventive action (CAPA). Approves and monitors CAPAs when required.
  • Reviews stability data to ensure product’s physiochemical characteristics are within historical trends and specification limits.
  • Acts as QA contact for cross-functional and cross-site projects identified by QA Management. Interacts with other departments ensuring compliance with applicable regulatory requirements.
  • Plans and conducts internal audits and external audits.  Manages all audit findings.  Maintains oversight of contracted audits when applicable.
  • Participates in the QMC as required and has oversight of the document management system and training records. 
  • Works with all departments to generate Management Reviews.
  • Maintains up to date Quality Assurance Agreements with vendors.  Prepares new QAA or updates current QAA as required.
  • Prepares QA memos, deviations, or investigations as required.
  • Works with CMC team during new product start-up, to determine Critical Quality Attributes and Critical Processing Parameter.
  • Interacts with Aurinia’s Regulatory Affairs and supports regulatory submission preparation.
  • Provides GMP training to all staff, as required.
  • Completes required Standard Operating Procedures (SOPs) training, as identified in training syllabus or job matrix. 
  • Follows approved policies and procedures as written.
  • Attends all required training sessions and obtains a passing score.
  • Ensures that the Quality Assurance department’s duties are carried out promptly, effectively and efficiently.
  • Other Duties as identified/assigned by management.
 
Requirements:
  • University degree in science or college diploma, combined with a minimum of 8 years of relevant experience in the pharmaceutical industry
  • Minimum of three (3) years in a supervisory/management role
  • Excellent knowledge of Good Manufacturing Practices (GMP) and technical knowledge of pharmaceutical processes, as well as of quality control and quality assurance concepts
  • Knowledge of the different pharmacopoeias (USP, BP, EP, etc.)
  • Experience in regulatory affairs would be an asset
  • Excellent command of English language both written and spoken
  • Knowledge of Microsoft applications
  • Superior GMP knowledge and experience (Health Canada, FDA) 
  • Attention to detail and follow through 
  • Ability to work independently as well as in a team environment 
  • Motivated with an ability to make quick, informed decisions 
  • Well-organized, able to multi-task and coordinate several projects at once
  • Approximately 20% travel is expected

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Accepted formats: PDF, Word Doc

Accepted formats: PDF, Word Doc