Director, External Manufacturing Compliance Oversight

7555-Janssen Pharmaceutica NV Legal Entity

Geel

Sur place

EUR 96 000 - 280 000

Plein temps

Il y a 5 jours
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Avantages offerts par ce poste

Annual bonus
Vacation days
Parental leave
Bereavement leave
Well-being reimbursement
Insurance plans

Résumé du poste

Johnson & Johnson is seeking a Director of External Manufacturing Regulatory Compliance Oversight to strengthen regulatory compliance across its External Manufacturing network. The role focuses on independent risk assessment, inspection readiness, and governance across global partners.

The position requires extensive GMP knowledge, leadership in quality/compliance, and experience with Health Authority inspections, CAPA governance, and risk management. Travel up to 25-40% is anticipated.

Qualifications

  • Education: Bachelor's Degree in Life Sciences, Engineering, Pharmacy, or related field; Advanced degree preferred.
  • Leadership experience: minimum 5 years in Quality, Compliance, Regulatory Compliance, or External Manufacturing.
  • Experience with Health Authority inspections, remediation programs, and supplier oversight.

Responsabilités

  • Provide independent oversight of regulatory compliance across External Manufacturing network.
  • Support inspection readiness activities and regulator interactions.
  • Assess oversight of CMOs, CDMOs, and critical external partners; review CAPAs and risk management.
  • Lead governance forums, share regulatory intelligence, and drive continuous improvement.

Connaissances

Regulatory compliance
GMP knowledge
Leadership
Risk management
Executive communication

Formation

Bachelor's Degree in Life Sciences
Advanced degree preferred

Description du poste

Johnson & Johnson is seeking a Director of External Manufacturing Regulatory Compliance Oversight to strengthen regulatory compliance across its External Manufacturing network. The role focuses on independent risk assessment, inspection readiness, and governance across global partners.

The position requires extensive GMP knowledge, leadership in quality/compliance, and experience with Health Authority inspections, CAPA governance, and risk management. Travel up to 25-40% is anticipated.

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