Manager, Quality Assurance
Innomar Strategies Inc.
- # Manager, Quality AssuranceApply: Remote, ON: Full time: Posted Today: R2616835Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!# **Job Details** The Manager, Quality Assurance (Consulting) is a hands-on people leadership role responsible for managing and developing a team of Sr. QA Specialists while directly supporting complex client and quality deliverables.The role 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. The Manager is accountable for timely, accurate and risk-based delivery across multiple client projects, builds productive internal and external relationships, and supports invoice reconciliation. Success requires strong ownership, initiative, sound judgment, pragmatic problem-solving and confident client-facing communication. **Primary Duties and Responsibilities:** * Lead and assign the day-to-day work of Sr. 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 timeframes.* 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 Management. **Experience and Education:** * 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. **Core Skills, Knowledge and Leadership Competencies:** * **Regulatory and technical expertise:** 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. Knowledge of natural health product requirements is an asset.* **Leadership and people development:** Proven ability to manage, motivate and develop employees; set clear expectations; provide practical training; delegate effectively; and foster accountability, collaboration and respectful professional relationships.* **Ownership and dependability:** Responsible, diligent and reliable, with consistent follow-through. Takes ownership of commitments and outcomes and completes work accurately and on time.* **Judgment and decision-making:** Comfortable making timely, risk-based decisions using available information. Thinks effectively in real time, identifies practical options and recognizes when escalation is appropriate.* **Initiative and continuous improvement:** Proactively identifies needs, volunteers for new or challenging work, speaks up when concerns arise and takes action to correct issues or improve processes.* **Complex project execution:** Able to lead complicated, multi-client projects, organize competing priorities, maintain attention to detail and work efficiently without compromising quality or compliance.* **Risk-based problem-solving:** Skilled in deviations, root cause analysis, CAPA and risk assessment. Identifies pragmatic, compliant solutions to operational and quality challenges.* **Client engagement and communication:** Demonstrates strong written, verbal, presentation, and public-speaking skills. Communicates clearly and confidently with clients, responds in a timely and appropriate manner, and builds credibility through professionalism, responsiveness, sound technical advice, and practical solutions to quality and compliance.* **Technical and Digital Proficiency:** Advanced proficiency in Microsoft Word and Excel, with the ability to quickly learn and adapt to new technologies and enterprise systems. Familiarity with AI tools and their business applications is considered an asset.* **Collaboration and adaptability:** Works effectively independently and in cross-functional, multidisciplinary teams. Adapts quickly, remains composed as priorities change and promotes positive, respectful and professional working relationships. **Working Conditions:*** May involve travel up to 20%.* Work shift is not required unless business needs change.
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