Senior Manager – Biotherapeutics Quality Integrator

Leiden Bio Science Park

Netherlands

On-site

EUR 120,000 - 160,000

Full time

4 days ago

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Job summary

Johnson & Johnson Innovative Medicine (J&J IM) seeks a Senior Manager, Product Quality Integrator for Biotherapeutics to oversee the quality strategy across Early Development to late-stage commercialization. The role requires coordinating Global Quality across CMC/VCT, approving HA submissions, and guiding QA resources for global product integration.

The position is Europe-based (Leiden or Cork) with potential travel up to 10% and leadership of QA teams spanning clinical to commercial lifecycle.

Qualifications

Bachelor's degree or university equivalent in a technical/scientific discipline such as Pharmacy, Biology, Biochemistry, Biotechnology, or Engineering.
8+ years’ experience in pharma/biotech industry.
Knowledge of cGMP standards, policies and procedures.
Ability to work across organizational boundaries and influence decision-making.

Responsibilities

Represents Global Quality on CMC and VCT teams and serves as liaison between VCT and Analytical groups.
Ensures Quality stage gate deliverables are achieved and QA is integrated across development to launch.
Reviews and approves filings (IND, IMPD, BLA, NDA, MAA) and supports audits.
Defines QA resources and leads cross-functional teams for integration from development through lifecycle.
Drives decision making and problem solving and ensures QA processes (PPQS, CA, PRA, complaints, escalations) are used globally.