DIRECTOR QUALITY

Job Description : DIRECTOR QUALITY COMPLAINCE NETHERLANDS International candidates welcome to apply Lead, coach, and develop the Quality Compliance team, ensuring clear priorities, effective decision-making, and consistent execution of compliance activities across the site. · Ensure the site remains compliant with applicable regulatory requirements, marketing authorization holder expectations, customer commitments, and internal quality standards. · Maintain a high level of inspection readiness by developing and implementing a proactive strategy that supports successful regulatory inspections across all relevant jurisdictions aligned with global regulatory expectations, including FDA, EMA, MHRA, PMDA, PIC/S, and other applicable health authority requirements. · Lead audit readiness activities and provide oversight during regulatory inspections, including preparation, inspection management, response coordination, remediation planning, and follow-up of commitments. · Oversee the planning, execution, and reporting of self-inspection programs across GMP subsystems, including Quality Systems, Quality Operations, Production, Facilities and Equipment, Quality Control, MSAT, and Supply Chain. · Maintain and continuously improve self-inspection procedures, tools, and templates to ensure alignment with ICH Q10, 21 CFR Parts 210/211, and evolving industry and regulatory expectations. · Support global alignment on regulatory expectations, inspection approaches, and compliance practices by working closely with global quality, regulatory, and operational stakeholders. · Act as a trusted compliance advisor on complex quality matters, providing practical guidance that protects the organization’s licenses, regulatory standing, and reputation. · Provide training, coaching, and guidance on compliance topics to strengthen quality culture, regulatory awareness, inspection readiness, and data integrity across the organization. Bachelor’s degree in for instance: Biochemistry, Life Science & Technology, Engineering and minimum of 20 years of relevant experience in related field. A Master’s degree can be substituted for 2 years of related experience. A Ph.D. degree can be substituted for 4 years of related experience. 12+ years of progressive experience in Quality Compliance, with a track record in self-inspection Deep expertise in utilities and critical systems, maintenance and calibration programs, and contractor-led service models. A minimum of 15 years of cGMP experience. Sound judgment and comfort operating in ambiguity—able to make decisions when precedent may not exist. Strong cross-functional leadership and stakeholder management Strong communications skills Excellent auditor skills. Strategic and critical thinking with quality rigor

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