For our partner Haleon, GI Life Sciences is looking for a QA FDA Compliance professional for our partner 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.