Vacancy number: A2500043
Johnson & Johnson Innovative Medicine - Leiden (Nederland)
For our client, Johnson & Johnson Innovative Medicine, we are looking for a Compliance Lead/ a.i. (deputy) head of QC .
Johnson & Johnson Innovative Medicine - Leiden (Nederland)
For our client, Johnson & Johnson Innovative Medicine, we are looking for a Compliance Lead/ a.i. (deputy) head of QC .
Keywords
- Management
- GMP
- QC
- Pharma/Biotech
- Laboratory Management Sytems
Profile
Based on the needs within the QCD Labs organisation, we are looking for a motivated Compliance Lead who enjoys working in a multidisciplinary environment.Main focus for the Compliance Lead includes, but is not limited to:
- 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 Non-conformances, Actions, Change Controls, etc. managed in Comet;
- Advice on phase appropriate GMP implementation and support by writing and reviewing procedures;
- Give support in writing Non-conformances, 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.
Who we're looking for
The ideal candidate has:- An M.Sc. in life sciences;
- At least 10 years of experience in a pharmaceutical environment;
- At least 5 years of experience in a GMP environment at a senior level;
- Experience with laboratory management systems;
- A proven track record in GMP compliance management;
- Excellent interpersonal skills and able to build strong relationships.
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;
- Co-ordination of Release and Stability testing and Out sourcing Co-ordination;
- 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, non-conformance management and management of the training system.
Company profile
Janssen Vaccines & Prevention B.V. is part of Johnson & Johnson, one of the biggest and most respected health care companies in the world. They are dedicated to bringing meaningful innovation to global health. Their teams focus on the discovery, development, manufacturing, and marketing of novel vaccines to prevent some of the most devastating and complex infectious diseases. These range from respiratory infections like respiratory syncytial virus (RSV) to human immunodeficiency virus (HIV) and pathogens of global concern, such as Ebola and COVID-19.In this organisation, entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are of crucial importance. They are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Janssen. The offices of Janssen Vaccines & Prevention are located in Leiden, The Netherlands.
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Additional vacancy information
| Reference | : | A2500043 |
| Contract | : | Temporary contract with CLS Services |
| Employment terms | : | Project for 6 months, might be extended. Full time on site, hybrid possible if needed. |
| Publication date | : | 3-7-2025 |
| Location | : | View location with Google Maps |
| Contactperson | : | Claudia Erwich-Faaij |
| +31 (0)88 22 77 555 |
CLS Services is a leading professional recruitment agency, specialised in the recruitment and secondment of people with a background in chemistry & life sciences.
