QA FDA Compliance

QA FDA Compliance

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 (, 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.

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