About This Role
This role is a hands-on people leadership position responsible for managing and developing a team of Senior QA Specialists while directly supporting complex client and quality deliverables. The Manager oversees Drug Establishment Licence (DEL) maintenance, foreign site approval activities, release of commercial drug products and clinical trial supplies to the Canadian market, and preparation and review of quality and compliance documentation. Success requires strong ownership, initiative, sound judgment, pragmatic problem-solving, and confident client-facing communication.
Responsibilities
- Lead and assign the day-to-day work of Senior QA Specialists, balancing client commitments, compliance risk, business needs, and established timelines
- Provide clear direction, coaching, mentoring, training, and cross-training to strengthen team capability, accountability, consistency, and readiness for changing priorities
- Remain hands-on in day-to-day quality activities and take ownership of complex or high-impact assignments, identifying issues early, making timely decisions within authority, and escalating appropriately
- Maintain importer Drug Establishment Licences and manage the approval process for foreign sites supporting multiple clients
- Ensure compliance activities associated with the importation of drugs, medical devices, and natural health products are performed in accordance with applicable Health Canada regulations and guidance
- Perform or oversee the release of commercial drug products and/or clinical trial supplies to the Canadian market for Innomar or clients, as required
- Maintain and review internal and client quality documentation, including SOPs, annual product quality reviews, stability reports, qualification and validation protocols and reports, artwork, and temperature studies
- Ensure deviations, corrective and preventive actions, product quality complaints, change controls, and associated trend analyses are completed in a compliant, thorough, and timely manner
- Provide expert consultation to clients on quality matters by assessing risks, evaluating potential impacts, and recommending practical, compliant, and sustainable solutions to support informed decision-making and business success
- Actively contribute to the development, maintenance, and continual improvement of GMP quality systems, including addressing deficiencies or inconsistencies when identified
- Advise other departments on Quality Assurance requirements, risks, and strategies
- Support or lead internal, client, third-party, and regulatory audits or inspections, including serving as lead auditor or audit host when required
- Support recall and mock recall activities, as required
- Build and maintain positive, productive relationships with internal stakeholders, current and prospective clients, foreign sites, and other external partners
- Participate actively in client meetings and presentations, communicate Quality positions clearly, and respond confidently to questions while remaining collaborative and solutions-focused
- Demonstrate initiative by volunteering for new responsibilities and adapting quickly to changing priorities, emerging issues, and unfamiliar situations
- Manage multiple projects efficiently and accurately, with strong follow-through and dependable completion within established time frames
- Provide subject matter expertise through the delivery of training, presentations, and seminars to internal teams, clients, and external organizations, fostering awareness, capability development, and compliance excellence
- Complete or support invoice reconciliation and quotation activities, as assigned
- Understand and comply with company confidentiality and privacy requirements
- Perform other duties and tasks assigned by Senior QA
About the Company
At Cencora, team members are united in their responsibility to create healthier futures, and every person is essential to delivering on that purpose. The company aims to improve the lives of people and animals everywhere.
