Global Quality Asset Lead – Advanced Therapies

Johnson & Johnson Co.; Wallingstown; On-site; EUR 86,000 - 148,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Supportive environment

Job summary

Johnson & Johnson Innovative Medicine, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Manager, Quality Asset Management within Advanced Therapies. The Senior Manager has end-to-end accountability for the quality strategy and quality aspects from Early Development through commercialization in Advanced Therapies products.

Key responsibilities include representing Global Quality on CMC and Value Chain teams, ensuring QA deliverables, approvals for regulatory

Qualifications

• Bachelor’s degree in a relevant field (e.g., Pharmacy, Biology, Biochemistry, Biotechnology, Engineering).
• 8+ years’ experience in the pharmaceutical/biotechnology industry.
• Knowledge of cGMP standards and regulatory processes.
• Ability to work across organizational boundaries and influence decisions.

Responsibilities

• Represent Global Quality on CMC and Value Chain Teams.
• Serve as liaison between VCT and Analytical groups; be the single Global Quality contact.
• Ensure QA deliverables and approvals for regulatory filings (IND, IMPD, BLA, NDA, MAA).
• Define QA resources for global and local QA of assigned products.
• Lead QA integration across development through launch and lifecycle management.

Skills

GMP Knowledge

Regulatory Submissions

Cross-functional Collaboration

Risk Assessment

Decision Making

Mentorship

Education

Bachelor’s degree in Pharmacy/Biology/Biotechnology

Job description

Johnson & Johnson Innovative Medicine, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Manager, Quality Asset Management within Advanced Therapies. The Senior Manager has end-to-end accountability for the quality strategy and quality aspects from Early Development through commercialization in Advanced Therapies products.

Key responsibilities include representing Global Quality on CMC and Value Chain teams, ensuring QA deliverables, approvals for regulatory