Senior Manager, Biotherapeutics Quality & Asset Integration

Get 360Pharma; Beerse; Sur place; EUR 110 000 - 140 000; Plein temps

Résumé du poste

Johnson & Johnson Innovative Medicine seeks a Senior Manager, Product Quality Integrator, to own the quality strategy for biotherapeutics from early development through commercialization and lifecycle management. You will lead QA teams across clinical, DS/DP, device, and packaging and coordinate with CMC/VCT to ensure regulatory readiness and lifecycle quality.

The role requires a bachelor’s degree in a technical field and at least 8 years in pharma/biotech, with strong cGMP knowledge and

Qualifications

• Bachelor’s degree in a scientific/technical field (pharmacy/biology/biochemistry/biotechnology/engineering)
• Minimum of 8 years’ experience in pharmaceutical/biotech industries
• Knowledge of cGMP standards, policies and procedures
• Demonstrated ability to influence across organizational boundaries
• Willingness to travel up to 10% (US/EMEA/APAC)

Responsabilités

• Represents Global Quality on CMC and VCT teams and serves as the single Global Quality contact
• Ensures quality stage gate deliverables are achieved
• Reviews/approves health authority submissions and supports audits
• Defines QA resources for global/local QA of assigned products
• Leads QA teams across clinical, DS/DP, device and packaging from development to launch and lifecycle
• Supports QA communication with External Manufacturers and Business Partners
• Ensures standard Global Quality processes are used and communicated across sites

Connaissances

Leadership

Cross-functional collaboration

Regulatory knowledge

Decision making

Travel readiness

Formation

Bachelor's degree in Pharmacy/Biology/Biochemistry/Biotechnology/Engineering

Description du poste

Johnson & Johnson Innovative Medicine seeks a Senior Manager, Product Quality Integrator, to own the quality strategy for biotherapeutics from early development through commercialization and lifecycle management. You will lead QA teams across clinical, DS/DP, device, and packaging and coordinate with CMC/VCT to ensure regulatory readiness and lifecycle quality.

The role requires a bachelor’s degree in a technical field and at least 8 years in pharma/biotech, with strong cGMP knowledge and