Senior Manager, Quality Asset Mgmt (Advanced Therapies)

Johnson & Johnson Co.; Schaffhausen; On-site; CHF 140,000 - 170,000; Full time

Job summary

Johnson & Johnson Innovative Medicine in Schaffhausen, Switzerland seeks a Senior Manager, Quality Asset Management. You will drive global quality strategy across Early Development through commercialization in Advanced Therapies.

The role requires leading QA across CMC, coordinating with VCT, and guiding regulatory filings while partnering with external manufacturers to ensure patient safety and product quality throughout the lifecycle.

Qualifications

• Bachelor’s degree in a relevant technical/scientific field.
• 8+ years in pharma/biotech industry.
• Knowledge of cGMP standards, policies and procedures.
• Demonstrated ability to work across organizational boundaries through presenting, influencing, negotiation and partnering.
• Ability to quickly assimilate new technologies, perform risk assessments and develop action plans.
• Flexible hours to accommodate US, EMEA and ASPAC work schedules; travel up to 10%.

Responsibilities

• Represents Global Quality on the CMC and Value Chain Teams.
• Liaises between VCT and Analytical group.
• Single point of Global Quality contact.
• Ensures Quality stage gate deliverables are achieved.
• Reviews and approves health authority submissions and related questions.
• Supports site QA for assigned products and audits.
• Defines QA resources for global and local QA of assigned products.
• Leads QA integration and sub-teams across development to launch and lifecycle.

Skills

cGMP knowledge

Cross-functional collaboration

Risk assessment

Regulatory filings

Travel readiness

Technology adoption

Education

Bachelor’s degree in Pharmacy, Biology, Biochemistry, Biotechnology, Engineering, or similar

Job description

Johnson & Johnson Innovative Medicine in Schaffhausen, Switzerland seeks a Senior Manager, Quality Asset Management. You will drive global quality strategy across Early Development through commercialization in Advanced Therapies.

The role requires leading QA across CMC, coordinating with VCT, and guiding regulatory filings while partnering with external manufacturers to ensure patient safety and product quality throughout the lifecycle.