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Senior Quality Associate​/Associé principal; e), Assurance qualité

Job in Charlottetown, PEI, Canada
Listing for: Merck Canada
Full Time position
Listed on 2025-12-31
Job specializations:
  • Quality Assurance - QA/QC
  • Healthcare
Salary/Wage Range or Industry Benchmark: 60000 - 80000 CAD Yearly CAD 60000.00 80000.00 YEAR
Job Description & How to Apply Below
Position: Senior Quality Associate/ Associé principal (e), Assurance qualité

Senior Quality Associate – Quality Assurance

In the Quality team, the Senior Associate, Quality Assurance is responsible for oversight of quality projects and programs to ensure compliance of the production, testing, and distribution of Aqua Vaccines, while seeking opportunities for improvement of established quality processes.

Main Responsibilities & Duties
  • Management of Quality Assurance projects with a focus on compliance, productivity, and improvement of quality metrics. Leads these teams through project planning, organization and tracking of project deliverables.
  • Preparation of risk assessments, protocols, Standard Operating Procedures, training materials and gap assessments.
  • Work closely with Quality Assurance stakeholders on multidisciplinary projects that require quality consultation; this may include management of multi‑stakeholder projects that directly influence compliance and manufacturing outcomes.
  • Complete Technical and Quality Agreements.
  • Work closely with Quality Assurance stakeholders to provide input into protocol development and to ensure protocols are compliant with our company's and GMP standards.
  • Review and approval of executed validation / qualification protocols and reports.
  • Manage Quality Assurance regulatory and internal inspection preparation. Participates in a lead support role during inspections.
  • Conducts site self‑inspections and Quality Assurance walkthroughs.
  • Release of equipment and facilities.
  • Supporting the implementation of our company's Animal Health Quality Manual as required.
  • Shared responsibility for the following quality systems: change controls, quality events and investigations, Corrective and Preventative Actions, and out of specification.
  • Provides initial assessment of quality events, investigations, Corrective and Preventative Actions, and OOS for completeness and compliance.
  • Leads cross functional teams (when required) in investigations and analysis to determine root cause and aids in the resolution of issues.
  • Involves site subject matter experts for final assessment and closure.
  • Approves deviations.
  • Preparation and approval of change controls and impact assessments.
  • Tracking and trending of all systems to ensure timely closure and follow up where required.
  • Other duties as required.
Qualifications & Experience

Minimum of a Bachelor of Science degree or equivalent. At least 5 years in Quality Assurance and/or current Good Manufacturing Practices facility operation experience.

  • Cross functional collaboration experience with multiple teams (indirect or direct leadership experience is an asset).
  • Proven ability to work independently due to the highly independent nature of this role.
  • Focused on achieving goals and persistent when faced with obstacles.
  • Adaptable to quick changes in required activities or duties.
  • Thinks critically to support the needs of Quality Assurance but also considers business impact.
  • Excellent communication skills, in both verbal and written form.
  • Language requirement:
    English.
Additional Preferences
  • Proficiency with business applications such as Adobe, MS Office, Word, Excel, Access, Project, Visio, and PowerPoint.
  • General knowledge of regulatory requirements for the pharmaceutical, biotechnology, or vaccine industry.
  • Good problem‑solving skills.
  • Experience in root cause analysis.
  • Work effectively in cross‑functional teams.
Health and Safety
  • Display Screen Equipment: > 2/3 time
  • Sit: > 2/3 time
  • Lift: (Close vision, distance vision and color vision: Yes)
Compensation & Benefits

Salary range: CAD $61,900 – $105,300. Benefits include bonus eligibility, long‑term incentive, health care, retirement, paid holidays and vacation.

Equal Opportunity Employer

We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Application Information

All candidates must have adequate legal work authorization in Canada. No company sponsorship is required.

Recruitment Details
  • Requisition : R376186
  • Job posting ends: 01/05/2026
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Position Requirements
10+ Years work experience
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