Senior Director, Regulatory Compliance, Large Molecule
Johnson & Johnson
full-time
Posted on:
Location Type: Office
Location: Leiden • Netherlands
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Job Level
About the role
- Lead a compliance team for Large Molecule Biologics
- Define GMP compliance strategy aligned with business priorities
- Oversee compliance across biologics lifecycle
- Ensure inspection readiness and respond to health authorities
- Develop audit programs and risk mitigation strategies
- Provide regulatory filings input
- Foster a culture of quality and continuous improvement
Requirements
- 10+ years of experience managing compliance teams
- Expertise in biologics modalities and GMP compliance
- Experience with FDA, EMA, or MHRA regulations
- Advanced degree preferred (MS, PhD)
- Proven leadership skills in compliance
- Experience with cell banks and biologics manufacturing is desirable
Benefits
- Competitive salary
- Flexible working hours
- Professional development budget
- Home office setup allowance
- Global team events
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
GMP compliancebiologics modalitiesregulatory filingsaudit programsrisk mitigation strategiesinspection readiness
Soft skills
leadershipteam managementquality culturecontinuous improvement
Certifications
MSPhD