QA FDA Compliance Project Manager
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.