3 дня назад
Senior Compliance Lead (Pharma)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Compliance Lead (Pharma): Managing the Geel site's internal audit program and external GMP inspection readiness with an accent on regulatory compliance, audit execution, CAPA management, and site-wide risk remediation. Focus on coordinating compliance personnel, evaluating regulatory changes, coaching inspection teams, and driving continuous improvement across quality and compliance operations.
Location: Geel, Antwerp, Belgium; onsite role
Company
Johnson & Johnson MedTech develops healthcare and medical technology solutions across Innovative Medicine and MedTech.
What you will do
- Manage the Geel site's internal audit program, including audit scheduling, auditor qualification, audit execution, reporting, response evaluation, and data entry.
- Lead external GMP inspection readiness and management for Health Authority and customer inspections, including mock inspections, front-room and back-room coordination, coaching, and daily reporting.
- Act as the compliance subject matter expert for site personnel, quality systems, projects, investigations, complaints, and field actions.
- Identify regulatory changes, perform gap analyses, implement Johnson & Johnson compliance standards, and drive remediation of compliance risks and CAPAs.
- Coordinate Geel-based compliance personnel and support compliance teams in Beerse, Geel, Athens, and Cork.
- Establish compliance metrics, training, procedures, benchmarking, and continuous improvement initiatives across the site.
Requirements
- At least 8 years of related experience in a GMP-regulated industry, including at least 3 years in regulatory compliance.
- Extensive knowledge of global GMP regulations and experience performing internal or external audits.
- Bachelor's degree in Science or a related field.
- Fluent Dutch and English, written and spoken.
- Strong analytical, communication, partnership-building, mediation, and risk-management skills.
- Ability to manage complexity and ambiguity, demonstrate business acumen, and deliver against urgent timelines.
Culture & Benefits
- Inclusive work environment guided by the Johnson & Johnson Credo.
- Collaboration with Quality, Regulatory Affairs, Operations, Product Quality Management, and regulatory compliance teams.
- Active participation in environmental, health, and safety procedures and improvement programs.
- Opportunities to benchmark industry standards through external groups such as PDA and ISPE.
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