Quality Assurance Manager

Posted 1 hour ago

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About the role

  • Quality Assurance Manager leading GMP compliance, DEL maintenance and Canadian drug-product release for Cencora. Managing QA specialists and advising pharmaceutical clients on regulated quality activities.

Responsibilities

  • Lead and assign the day-to-day work of Sr. QA Specialists
  • Provide direction, coaching, mentoring, training and cross-training
  • Perform hands-on quality activities and own complex or high-impact assignments
  • Maintain importer Drug Establishment Licences and manage foreign site approval processes
  • Ensure compliance with Health Canada regulations and guidance for drug, medical device and natural health product importation
  • Perform or oversee release of commercial drug products and clinical trial supplies to the Canadian market
  • Maintain and review SOPs, annual product quality reviews, stability reports, qualification and validation documentation, artwork and temperature studies
  • Ensure deviations, CAPAs, product quality complaints, change controls and trend analyses are completed compliantly and on time
  • Provide expert quality consultation to clients through risk assessment and practical solution recommendations
  • Contribute to development, maintenance and continual improvement of GMP quality systems
  • Advise departments on Quality Assurance requirements, risks and strategies
  • Support or lead internal, client, third-party and regulatory audits or inspections
  • Support recall and mock recall activities
  • Build relationships with stakeholders, clients, foreign sites and external partners
  • Participate in client meetings and presentations and communicate Quality positions
  • Manage multiple projects and deliver work within established timeframes
  • Deliver training, presentations and seminars to internal teams, clients and external organizations
  • Complete or support invoice reconciliation and quotation activities
  • Comply with confidentiality and privacy requirements
  • Perform other duties assigned by Senior QA Management

Requirements

  • Bachelor's degree in a pharmaceutical, scientific or healthcare-related field, such as chemistry, biology, microbiology, pharmacy or pharmacology
  • Minimum 10 years of Quality Assurance experience in a regulated pharmaceutical or healthcare environment
  • Minimum 3 years of people management or supervisory experience
  • Demonstrated experience with Health Canada requirements, GMP compliance, drug importation and Drug Establishment Licences
  • Experience conducting vendor audits and hosting or co-hosting client, third-party or regulatory audits is considered an asset
  • Experience working as a consultant is considered an asset
  • Experience with natural health products is considered an asset
  • Comprehensive knowledge of the Food and Drugs Act, Health Canada GMP regulations and associated guidance
  • Strong working knowledge of DEL requirements, importation controls, GMP documentation, risk assessment and quality systems
  • Proven ability to manage, motivate and develop employees; set clear expectations; provide practical training; delegate effectively; and foster accountability, collaboration and respectful professional relationships
  • Skilled in deviations, root cause analysis, CAPA and risk assessment
  • Strong written, verbal, presentation, and public-speaking skills
  • Advanced proficiency in Microsoft Word and Excel
  • Ability to quickly learn and adapt to new technologies and enterprise systems
  • Works effectively independently and in cross-functional, multidisciplinary teams
  • May involve travel up to 20%

Benefits

  • Medical, dental, and vision care
  • Backup dependent care
  • Adoption assistance
  • Infertility coverage
  • Family building support
  • Behavioral health solutions
  • Paid parental leave
  • Paid caregiver leave
  • Training programs
  • Professional development resources
  • Mentorship programs
  • Employee resource groups
  • Volunteer activities

Job title

Job type

Full Time

Experience level

SeniorLead

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

RemoteCanada

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