Deputy Head Of QC / Compliance Lead

Compliance Lead/ a.i. (deputy) head of QC 

Location: Leiden - Hybrid working - 3 days a week on site minimum

Duration: 6 months 

Hours: Full time 

Department

The Quality Control Development (QCD) group within the Analytical Development (AD) Department of the Advanced Therapeutics AD sector of J&J Innovative medicine. 

The QCD Labs group focuses on supporting production and laboratory activities with:

• Inspection, release and change management of incoming production raw materials and laboratory chemicals.

• Sample and Material receipt, handling, storage and forwarding.

• Maintaining controlled state of production clean room and production utilities by environmental and utility monitoring programs.

• Coordination of Release and Stability testing and Outsourcing Coordination.

• Internal release and stability testing for clinical products, including culturing of cells.

• Ensuring the availability and maintenance of qualified equipment used in the laboratories.

• Compliance support to ensure high quality of documents, nonconformance management and management of the training system.

Based on the needs within the QCD Labs organization, we are looking for a motivated Compliance Lead who enjoys working in a multidisciplinary environment.

roles and responsibilities

• Act as deputy Head of QC by reviewing and approval of Qualification Study Plans and Reports related to assay qualifications / equipment validations and all supporting documentation. 

• Take lead in the Compliance Focus team meetings related to the progress of Nonconformances, Actions, Change Controls, etc managed in Comet.

• Advice on phase appropriate GMP implementation and support by writing and reviewing procedures.

• Give support in writing Nonconformances, Actions, where needed.

• Representative of QCD in Governance meetings, like GGB.

• Ensuring that a high level of Quality is maintained, with adherence to the Quality KPIs.

how to succeed

• Master’s degree in a life science study or equivalent job experience

• Minimum of 10 years of experience in a pharmaceutical environment.

• Minimum of 5 years in a GMP environment at a senior level.

• Proven track record in GMP compliance management preferably.

• Experienced with laboratory management systems.

• Developed interpersonal skills and able to build strong relationships.

• Flexible and accurate.

• You are motivated and have a positive can-do mentality.

• Good communication skills in English, written and verbally. (Dutch is a nice to have not essential) 

benefits

This role offers a very competitive hourly rate. This contract will run for 6 months with potential extension. 

you are welcome here

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow.

Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina.

We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. The pay rate for this role will depend on how you are paid. 

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.