About the role
CDS provides outsourced QA services to pharmaceutical clients. We are hiring an experienced Quality Assurance Specialist based in Winnipeg to assume a recent retiree’s responsibilities and ensure uninterrupted, high-quality QA support for our clients. This is a client-facing role that combines hands-on quality work with leadership of quality systems and regulatory readiness.
Key responsibilities
- Lead QA activities for multiple pharmaceutical clients, including oversight of day-to-day quality operations.
- Maintain and update quality documentation including SOPs, Forms, batch records, controlled documents, and document control systems.
- Manage GMP/GxP compliance, internal audits, supplier qualification, quality agreements and readiness for regulatory inspections.
- Investigate deviations and lead CAPA with root-cause analysis and verification of effectiveness.
- Review and approve complaints, Annual Product Reviews, change controls, validation deliverables, stability data, labels and release documentation.
- Train and mentor client and CDS staff on quality systems and procedures.
- Communicate clearly with client contacts and CDS leadership; prepare concise quality reports and handover documentation.
Required qualifications
- 5+ years QA experience in pharmaceutical or biotech environments preferred.
- Strong working knowledge of GMP/GxP, quality systems, CAPA, change control, and document control.
- Demonstrated experience conducting audits and managing regulatory interactions.
- Post-secondary degree in life sciences, pharmacy, engineering, or related field.
- Excellent written and verbal communication and client-facing skills.
- Proficiency with MS Office.
- Ability to work on-site in Winnipeg and travel to client sites as required.
Preferred qualifications
- Experience supporting small-to-mid-size pharma clients or familiarity with Medicure.
- Certifications such as ASQ or equivalent QA credentials.
- Experience with validation (IQ/OQ/PQ), stability and risk management frameworks.
What CDS offers
- Competitive compensation commensurate with experience.
- Opportunity to lead QA for multiple clients and shape quality systems.
- Supportive team environment and flexible work arrangements where appropriate.
- Structured handover and knowledge transfer from the retiring incumbent.
How to apply
Please submit a resume and brief cover letter highlighting relevant QA experience and availability.
Email applications to [email protected] with subject line: Quality Assurance Specialist — Winnipeg.
Applications will be reviewed on receipt and the role will remain open until filled.
Benefits:
- Dental care
- Extended health care
- Life insurance
- On-site parking
- Paid time off
- RRSP match
Application question(s):
- This position is located in Winnipeg, MB. Are you based in Winnipeg and able to work on-site?
- How many years of pharmaceutical QA experience do you have?
- Do you have a post-secondary degree in life sciences, pharmacy or a related field?
Work Location: In person
