Senior External Supplier QA & Compliance Lead

Johnson & Johnson Innovative Medicine; Little Island; On-site; EUR 73,000 - 115,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Job summary

Johnson & Johnson Innovative Medicine is seeking a Quality professional to lead supplier QA and govern external manufacturers. The role involves ensuring cGMP compliance, managing supplier audits, and driving quality programs across the supply chain.

You will collaborate with internal teams to review quality documentation, implement improvements, and ensure timely batch releases while maintaining high regulatory standards. Beerse, Cork, and related sites may apply.

Qualifications

• Bachelor's degree in Science, Engineering or technical subjects.
• Minimum of 6 years of experience in Pharmaceuticals or other regulated environments.
• Minimum of 4 years in Quality or Compliance is preferred.
• Strong communication skills in English.

Responsibilities

• Supplier management and QA contact for External Manufacturer/Supplier.
• Lead qualification during supplier selection and audits.
• Negotiate and approve Quality Agreements with External Manufacturers.
• Develop, implement and maintain quality systems for external suppliers.
• Provide cGMP compliance support and investigate quality issues.
• Drive GMP implementation for external packaging and labeling.
• Monitor KPIs, review batch records, and ensure timely releases.
• Review regulatory documents and ensure compliance with submissions.

Skills

Communication skills

English proficiency

Analytical skills

Independent work

cGMP knowledge

Auditing external suppliers

Team leadership

MS Office

Regulatory knowledge (FDA/ICH)

Project management

Education

Bachelor's degree in Science/Engineering/Technical

Tools

TruVault

COMET

Job description

Johnson & Johnson Innovative Medicine is seeking a Quality professional to lead supplier QA and govern external manufacturers. The role involves ensuring cGMP compliance, managing supplier audits, and driving quality programs across the supply chain.

You will collaborate with internal teams to review quality documentation, implement improvements, and ensure timely batch releases while maintaining high regulatory standards. Beerse, Cork, and related sites may apply.