Freelance Quality Control Product Lead (Yacht Life Sciences) (ZZP)

We would like to receive a CV that clearly shows that you meet the strict requirements. Make this clear in your motivation letter.

Job Description:

Yacht Life Sciences has a vacancy for a QC Product Lead to work within the Quality department, Johnson & Johnson Innovative Medicine in Leiden.

The successful candidate needs to understand the QC testing environment, has proper stakeholder management skills and a relevant educational background. The candidate is responsible for overseeing the end-to-end product testing within Leiden QC for a specific product.

About the Department:

The Leiden Quality Control department is a Business Unit within the Leiden Janssen Biologics site, a biotherapeutics and advanced therapies manufacturing site that is part of the Janssen Supply Chain. The Leiden QC Large Molecule department is responsible for raw material, in-process and release testing for products manufactured at the site. Additionally, the Leiden QC LM department has a unique global responsibility and exposure by being the stability testing hub for large molecule products within Janssen Supply Chain, and by partnering with multiple CMOs to perform the release testing. The department is structured in different testing laboratories and supporting teams, which are divided based on specific techniques and/or expertise.

Responsibilities:

• Responsible for the end-to-end product testing process within Leiden QC and understands the manufacturing site(s) and testing allocation(s) of product(s).

• Ensure on-time delivery of results per agreed timelines.

• Demonstrates decisive planning capability within a dynamic environment.

• Experience with managing Change Controls within a GMP regulated environment.

• Acting as subject-matter expert on release and stability processes of Leiden QC (including change control)

• Being the point of contact of Leiden QC within the network organization and partners with customers (e.g., JSC manufacturing sites, PQM, planning) to ensure flawless experience.

• Leads and drives continuous improvement projects.

• Adhering to compliance best practices, EHSS regulations, and lean principles.

• Maintaining compliance with all company policies and procedures.

Job requirements:

• BSc/HBO (or equivalent) or Master’s degree in bioscience, biotechnology, biochemistry, pharmacy biomedicine, process technology

• >3 years of relevant working experience in pharmaceutical or related industry;

• Experience with change controls in GMP environment

• Experience with SME QC release testing/ stability

• Product Lead role: managing products

• Advanced knowledge on lab systems and lab environment, data integrity and data management

• Proactive stakeholder management

• Knowledge of statistical data analyses

• Lean/BE experience

We would like to receive a CV that clearly shows that you meet the strict requirements. Make this clear in your motivation letter.