Senior Manager, Quality Asset Management

About the role

Johnson & Johnson Innovative Medicine, part of the Johnson & Johnson Family of Companies, is recruiting a Senior Manager, Quality Asset Management within Advanced Therapies. The role carries end-to-end accountability for the quality strategy and quality aspects of Advanced Therapies products, from early development through commercialization. It is based in Schaffhausen, Switzerland.

Key responsibilities

• Represent Global Quality on the Chemistry, Manufacturing and Controls (CMC) and Value Chain (VCT) teams, and act as the single point of Global Quality contact
• Review and approve health authority submissions (IND, IMPD, BLA, NDA, MAA) and related questions, and support audits
• Define and oversee the QA resources for assigned products and lead the Quality new product integration and sub teams
• Ensure quality throughout clinical, DS, DP, FF and device development through launch and the product lifecycle
• Support site representation on CMC and VCT teams and liaise with external manufacturers and business partners
• Manage complaints, participate in product safety management teams and coordinate complaint trend investigations
• Prepare the PPQS, support criticality analysis, and ensure Global Quality processes are applied consistently across sites
• Contribute to product strategy, value chain mapping, regulatory filings and business continuity, and escalate issues and drive quality decisions

Required profile

• Bachelor's degree in Pharmacy, Biology, Biochemistry, Biotechnology, Engineering or a similar technical/scientific field
• Minimum 8 years' experience in the pharmaceutical or biotechnology industry
• Knowledge of cGMP standards, policies and procedures
• Ability to work across organizational boundaries through presentation, influence, negotiation and partnership
• Flexible hours to cover US, EMEA and ASPAC schedules, and up to 10% domestic and international travel
• Preferred: Master's degree, biotech/vaccine/sterile manufacturing knowledge, technology transfer, process development/validation, quality systems (change control, CAPA), regulatory filing experience and API/drug product stability experience