C&Q Lead

C&Q Lead – Netherlands, Nijmegen – 6 Months Initial Contract
Our client is currently seeking the skills of a C&Q Lead to join their team.
Our client develops and delivers life changing medicines to millions of people globally and as part of their growth. With their Drug Substance (DS) manufacturing network growing rapidly, they are committed to growing their portfolio of commercial biologics products supplied worldwide – and this is your opportunity to be involved!

What you’ll do:

Drive a quality culture, ensure VMP approval, finalise SIA, and maintain GMP compliance through strong engagement with client quality stakeholders.
Build and execute the C&Q plan (from concept through execution), including risk assessments, supplier evaluations, scheduling, and resource planning aligned to project stages.
Oversee system transition from mechanical completion to commissioning, manage testing, protocols, reporting, system acceptance, and ensure timely, compliant documentation delivery.
Manage SHE requirements, safe system start-up, live system control, stakeholder collaboration (including GVLMS use), and lead/prepare C&Q resources to meet project schedule and budget.

What you’ll need:

Strong technical understanding of manufacturing technologies (e.g. OSD, Aseptic Filling, Warehouse, Biotech).
Degree‑qualified (or equivalent) in Science/Engineering with extensive C&Q experience in GMP environments.
Proven expertise in CQV lifecycle delivery, including concept, implementation, and operational support.
Demonstrated application of risk‑based validation principles in line with industry best practice.
Solid knowledge of regulatory standards and guidelines (ICH Q7/Q9, Eudra Lex Vol. 4, ASTM E2500, ISPE GAMP 5 & Baseline Guide
5).

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