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This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.
Job Responsibility:
Lead, supervise, coach and support a QA Release team of ~10 employees
Plan, coordinate and monitor batch file review activities
Ensure engagement, development and well‑being within the team
Manage and control finished product release for sterile drugs and medical devices
Review and approve deviations/events linked to the manufacturing process
Monitor and continuously improve release performance and associated KPIs
Prepare and present KPI results to site leadership, regional and global Quality teams
Serve as the QA Release representative for interactions with Manufacturing, Supply Chain, CMOs/3rd parties, Product Development, Corporate QA
Ensure efficient and compliant communication across departments
Ensure updates of quality documentation, SOPs and quality agreements
Support internal & external audits (auditor and auditee roles)
Contribute to quality training initiatives, including GMP awareness and training sessions
Lead release process improvements locally and implement global initiatives
Participate actively in Enterprise Management Systems (EMS), 6S, and improvement projects
Requirements:
Degree in Science or Engineering
an advanced degree is preferred
Proven experience in a similar QA Release or QA leadership role
Demonstrated experience in people management
Experience with GMP requirements (EU GMP, EudraLex Volume 4) and medical device regulations
Strong knowledge of quality systems, compliance expectations and release processes
QP delegate experience/training is an asset
Strong analytical mindset and structured problem‑solving approach
Excellent communication, presentation and stakeholder‑management skills
Ability to work under pressure and adapt to change
Strong organizational skills and sense of ownership
Fluency in French and working knowledge of English (required)