Our 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 Primary Duties And Responsibilities

• May manage a team of QA Specialists, assigning day to day activities and providing regular direction, mentoring, and coaching to the team.
• Maintenance of importer Drug Establishment Licenses (DELs) and the approval process for a large number of foreign sites for multiple clients.
• Ensure that all compliance activities associated with the importation of drugs, medical devices and natural health products are executed in compliance with Health Canada’s regulations and guidelines.
• Release of commercial drug product and / or clinical trial supply to the Canadian market for Innomar or customers as required.
• Coordinate with clients and/or foreign sites for the receipt, review and updates to master documents to ensure compliance to GMPs and in relation to product release activities.
• Maintain and review in-house and client-based quality documents, e.g. SOPs, APQR, stability reports, qualification / validation protocols and reports, artwork, temperature studies etc.
• Ensure that deviation investigations are completed in a compliant manner, including report generation and any associated trend analysis.
• Ensure that product quality complaints (PQCs) are completed in a compliant manner, including report generation and any associated trend analysis.
• Ensure that change control requests are completed in a compliant manner, including change request generation, execution and close out, and any associated trend analysis.
• Actively contribute to the development, maintenance and improvement of the Innomar GMP Quality Systems.
• Participate in and support project teams and advise other departments on Quality Assurance issues and strategies, when required.
• Provide support during audits / inspections (i.e. internal, client, third party or regulatory agencies), assuming the role of lead auditor / audit host as required.
• Provide support during recall / mock recall events as required.
• Build and maintain a positive and productive liaison with internal and external contacts, including interfacing with potential clients.
• Participate in and support project teams and advise other departments on Quality Assurance issues and strategies, when required.
• Demonstrate ability to effectively prioritize, coordinate and complete multiple projects within established timeframes.
• Provide support as a member of QA Management for the development / revision and implementation of QA policies and procedures as required.
• Understand and apply company Confidentiality and Privacy Agreements.
• Other duties and tasks that may be assigned by Senior QA Management.

Experience And Educational Requirements

• Bachelor’s degree in a pharmaceutical or healthcare related field (e.g. chemistry, biology, microbiology, pharmacy, and pharmacology).
• Minimum of 10 years’ experience in Quality Assurance.
• Minimum of 3 years’ experience in a supervisory role.
• Experience in conducting vendor audits is considered an asset.
• Experience in hosting/co-hosting client audits is considered an asset.
• Experience working in an Operations environment or with drug importation is considered an asset.

Minimum Skills, Knowledge And Ability Requirements

• Comprehensive knowledge of the Food and Drugs Act, Health Canada GMP regulations and associated guidelines.
• Maintenance of importer Drug Establishment Licenses (DELs, MDELS and Site License) and the approval process for a large number of foreign sites for multiple clients.
• Demonstrated GMP knowledge and adherence to GMP principles.
• Demonstrated leadership abilities in a cross-functional, multi-disciplinary team environment.
• Demonstrated ability in the effective management of deviations, root cause analysis, and CAPA implementation.
• Significant experience in the review and approval of GMP compliance related documentation and reports.
• The ability to identify pragmatic solutions to compliance / operational problems and challenges.
• Strong attention to detail, proven data analysis skills and the ability to present these findings effectively.
• Ability to work both independently and in a team environment, always promoting positive, respectful and professional relationships.
• Strong proficiency in common office applications (e.g. MS Word, Excel, PowerPoint, Outlook, Adobe Acrobat, etc.) and the ability to achieve rapid fluency in business related electronic applications/platforms (e.g., eQMS, EMS, WMS, CRM, etc.).
• Excellent written and verbal communication skills.
• May involve travel (up to 20%).

The successful candidate will (requirement)/may (asset) have daily contacts with unilingual English-speaking customers, patients or peers from cross-functional teams.

What Cencora offers We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more.

Full time

Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

Accessibility Policy Cencora is committed to fair and accessible employment practices. When requested, Cencora will accommodate people with disabilities during the recruitment, assessment and hiring processes and during employment. Affiliated Companies Affiliated Companies: Innomar Strategies