Senior Quality Assurance Specialist – Consultant

This is a fully remote position, open to applicants in Canada.

📋 Description

• Provide support for Cencora’s pharmaceutical commercialization services and patient/provider assistance in Canada via Innomar Strategies.

• Assist in the execution of quality-related tasks and activities within the Innomar QA Consultancy group.

• Manage importer Drug Establishment Licenses and approve foreign sites for a variety of clients.

• Collaborate with clients and foreign sites to receive, review, and update master documents ensuring GMP compliance and product release.

• Facilitate the release of commercial drug products and clinical trial supplies to the Canadian market.

• Evaluate manufacturing and packaging records, Certificates of Analysis, Certificates of Manufacture, and other product release documentation.

• Prepare quality performance indicators and client-specific report metrics, assuming the role of Team Lead when necessary.

• Maintain and review SOPs, APQRs, stability reports, qualification and validation protocols and reports, artwork, and temperature studies.

• Execute deviation investigations, product quality complaints, and change control requests, including reports and trend analysis.

• Assist in the development, revision, and implementation of QA policies and procedures.

• Keep copies of client and foreign-site documents and submissions to Health Canada for easy retrieval.

• Assist with internal, client, third-party, and regulatory audits and inspections.

• Support client and internal recalls as well as mock recalls, taking on the role of Team Lead when necessary.

• Communicate with internal and external contacts, including prospective clients.

• Engage in project teams and provide guidance to departments on Quality Assurance matters and strategies.

• Travel may be required up to 20%.

⛳️ Requirements

• A Bachelor’s degree in a pharmaceutical or healthcare-related discipline, such as chemistry, biology, microbiology, pharmacy, or pharmacology.

• At least 5 years of experience in Quality Assurance.

• Certification in Regulatory Affairs or Quality Assurance is a plus.

• Experience in conducting vendor audits is advantageous.

• Experience in hosting or co-hosting client audits is beneficial.

• Experience within an Operations environment is considered an asset.

• Thorough understanding of the Food and Drugs Act, Health Canada GMP regulations, and related guidelines.

• Proven ability to prioritize, coordinate, and complete multiple projects within set timelines.

• Demonstrated skills in deviation management, root cause analysis, and CAPA implementation.

• Capable of identifying practical solutions to compliance and operational challenges.

• Strong attention to detail and data analysis abilities.

• Comfortable working both independently and collaboratively within a team.

• Proficiency in MS Word, Excel, PowerPoint, Outlook, Adobe Acrobat, eQMS, EMS, WMS, CRM, productivity tools, and Quality Management Systems.

• Exceptional written and verbal communication skills.

• Familiarity with GCP, GMP, GDP regulations, and data integrity principles.

• Ability to work under general supervision and manage workload efficiently.

• Skills in identifying straightforward problems and applying established solutions.

• ASQ Certified Quality Auditor, ISO 9001 Lead Auditor, or equivalent is preferred.

🏝️ Benefits

• Comprehensive medical, dental, and vision care.

• Backup dependent care support.

• Adoption assistance programs.

• Infertility coverage options.

• Family building support services.

• Behavioral health solutions available.

• Paid parental leave provided.

• Paid caregiver leave offered.

• Opportunities for training programs.

• Access to professional development resources.

• Mentorship programs available.

• Employee resource groups for various interests.

• Opportunities for volunteer activities.