Sr Mgr External Clinical Supply Quality

J&J FAMILY OF COMPANIES

Schaffhausen, Switzerland
Hybrid
10+ years pharmaceutical quality experience
External manufacturer management
Cgmp compliance and regulatory oversight
Johnson & Johnson is seeking a Senior Manager for External Clinical Supply Quality to oversee quality assurance and compliance for external manufacturers in clinical development of biotherapeutics. The ideal candidate will have extensive experience in pharmaceutical quality roles, particularly in external manufacturing, and will contribute to innovative healthcare solutions

Job Summary

  • This role provides Quality Assurance, Compliance, and Management oversight for external manufacturers involved in clinical batch production for proteins and advanced therapeutics.
  • The position drives quality activities from first-in-human studies through Phase 3 and supports the transfer process to the IMSC organization.
  • Candidates must demonstrate strong analytical thinking and leadership skills to manage complex operational contexts with multiple external partners globally.

Matching Summary

Match Score: 85

Johnson & Johnson is seeking a Senior Manager for External Clinical Supply Quality to oversee quality assurance and compliance for external manufacturers in clinical development of biotherapeutics. The ideal candidate will have extensive experience in pharmaceutical quality roles, particularly in external manufacturing, and will contribute to innovative healthcare solutions.

Skills & Requirements

Must-have

  • 10+ years pharmaceutical quality experience
  • External manufacturer management
  • cGMP compliance and regulatory oversight
  • FDA/EMA regulated environment
  • Supplier qualification and monitoring
  • Aseptic and biological manufacturing knowledge

Nice-to-have

  • ISO 9001 Lead Auditor certification
  • Cross-functional global collaboration
  • Strategic quality leadership skills
  • Negotiation and relationship building
  • Risk-based quality approaches

Key Requirements

  • Minimum 10+ years in pharmaceutical quality roles
  • University degree in Life Science or Engineering
  • Auditor Qualification compliant with ISO 9001 and EU-GMP
  • Experience in FDA/EMA regulated chemical/pharmaceutical environment
  • Fluent in English written and spoken

Work Rights

Not specified

Tailored Resume

Cover Letter