QA FDA Compliance Project Manager

Location: Nyon, Vaud

Contract Type: Temporary or Konsult - 1 year

Client: Haleon

Your mission:

Lead and coordinate the FDA compliance implementation project to ensure full remediation and readiness prior to any product launch.

Key Responsibilities:

• Lead FDA compliance activities with selected team members.
• Monitor progress and ensure timely completion of remediation actions identified during the FDA assessment.
• Escalate risks or issues related to the remediation plan to relevant stakeholders.
• Provide coaching and support to all project participants.
• Develop and update documentation (procedures, work instructions, risk assessments) related to the FDA project.
• Partner with SOP owners and Inspection Readiness SMEs to assess training needs for new or revised SOPs.
• Conduct Gemba walks to identify and address potential compliance gaps.
• Organize and coordinate targeted training sessions as needed.
• Support governance and logistics for mock inspections and FDA audits (e.g., backroom setup, SME support).
• Provide guidance on data integrity (DI) events and deviations.
• Ensure robust auditing processes and inspection readiness.

Candidate Profile:

• University degree in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy, or a related scientific field.
• Minimum 10 years of experience in the pharmaceutical industry, specifically in Quality Assurance with exposure to production operations.
• Proven experience in project management and cross-functional team leadership.
• Previous experience in people management (direct or indirect).
• Experience in highly regulated environments, including FDA inspections (GMP, PAI).
• Fluent in French and English.
• Strong knowledge of GMP and regulatory expectations.
• Experience in GxP auditing (internal/external).
• Ability to influence key decision-makers and drive change.
• Excellent communication and interpersonal skills.

Gi Life Science is part of Gi Group Holding, a global ecosystem of HR services and consulting that supports the development of the labour market and helps to change people's lives in 37 countries around the world. In Switzerland we operate with the brands Gi Life Sciences, Gi Group, Grafton and Bautech Personal. We are active in temporary, permanent and professional staffing as well as in a variety of complementary HR Services. With a direct presence in 40 locations across Switzerland and over 200 employees, we are one of the leading staffing companies in the Swiss recruitment market. Gi Life Sciences is specialist for Temporary and Permanent staffing in the Life Science sector, as well as a valuable partner for many other HR Solutions. We believe in experts talking to experts: all our professionals are certified in scientific sector, meaning that they are able to understand your needs and support you at 360°.