Head of AVA/Mycoplasma Quality Control

jj

Leiden

On-site

EUR 69,000 - 120,000

Full time

9 days ago

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Job summary

Janssen Biologics B.V in Leiden, NL, seeks a Manager AVA/Mycoplasma Quality Control to lead the AVA/Mycoplasma QC team within the Leiden QC labs. The role requires a strong background in release of marketed products, viral/microbial methods, and people management.

You will mentor Supervisors and specialists, drive data integrity and regulatory compliance, manage budgets, and collaborate with QA, manufacturing, and external partners to ensure timely testing and continuous improvement of QC

Qualifications

Masters / PhD or equivalent in virology, microbiology, life sciences, biotechnology or equivalent.
5–10 years in viral and microbiological method development and validation.
Experience leading a 5–10 direct reports team.
Regulatory knowledge (FDA, EU) in general and viral/microbiological topics.
Strong leadership, problem-solving and process excellence experience.
Prior experience with Next Gen Sequencing and rapid microbiology methods preferred.

Responsibilities

On time delivery of release and stability sample testing results for the AVA/myco team.
Ensure tasks comply with safety policies, quality systems and cGMP requirements.
Set goals and KPIs for department and monitor performance.
Ensure data generation, trending and integrity per regulatory requirements.
Lead Supervisors and specialists with operational and strategic guidance.
Collaborate with QA, Stability Owners, Development, Manufacturing and other stakeholders.