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Janssen Biologics is currently recruiting a Laboratory Compliance Specialist to be based in Leiden (Netherlands) within the department of QC Safety & Compliance. The successful candidate needs to have strong knowledge of (Regulatory) Compliance and GMP guidelines and be someone who takes ownership, is accountable and result driven. You will be working within a small team of Compliance and Safety specialist and able to build a broad network within the QC organization and JBV site.

About the Company

Janssen Biologics B.V. is part of Johnson & Johnson Innovative Medicine. Janssen Biologics B.V. is a multinational pharmaceutical company that has been for more than 25 years a leader in the field of biomedicines. Through the dynamic science of biotechnology, we continue to seek innovative ways to treat cancer, cardiovascular and metabolic diseases, and immune-mediated inflammatory disorders, such as rheumatoid arthritis and psoriasis. Janssen Biologics is part of the Johnson & Johnson family of companies.

About the Department

The Leiden Quality Control Leiden 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. The QC Safety & Compliance department focusses on coordination of all EHS and Compliance matters for and within all QC departments.

The responsibilities & the impact YOU will have

• You ensure overall compliance to regulatory cGMP requirements, global standards, procedures, etc. and identify risks that the organization faces and advise on how to avoid and address missteps that could result in (inspection) observations and/or quality incidents.

• You are responsible for developing compliance programs, reviewing company policies, and advising management on possible risks.

• You are responsible for coordinating timely reporting and processing of compliance/quality incidents and owner of the quality metrics for the QC laboratories.

• You are advisor and impact assessor on quality incidents, inspection observations, change controls, gap assessments and other compliance related topics.

• As Compliance Specialist you represent the Leiden QC laboratories in platform meetings.

• As QC Leiden Single Point of Contact about compliance matters, you attend internal and external audits in the coordinating role as Primary Contact for Quality Control and are responsible that timely responses are given on any recommendation and/or observation that is made by the inspectors in cooperation with the Quality Assurance department.

• You provide compliance trainings and make sure the information in the training is correct and up to date.

• You write, contribute to or coordinate periodic GMP reports such as trend reports and site master file

• You coordinate or perform compliance Gemba walks/spot checks to frequently evaluate lab compliance and to ensure that work on the labs is done in a compliant matter.

• When there are any doubts and questions about compliance on the lab, you will be able to (find and) give advice.

Qualifications

• Minimal BSc education (Pharmaceutical Sciences, Life Sciences, or a related field is a pre) with >3 years experience in the pharmaceutical industry

• Having experience working in a (pharmaceutical) laboratory environment is desirable

• High proficiency in English and strong collaboration and communication skills

• Planning skills, ability to prioritize multiple commitments and process minded.

• Continuous improvement oriented and experience in performing (improvement) projects.

• Taking the leadership role to coordinate compliance initiatives and to ensure deliverables are met amongst the different departments without hierarchical context.

• Analytical and strategic thinking and (technical) problem solving.

• Pro Active, works independently, takes actions in the absence of specific instruction, and can write protocols/reports, business correspondence and procedures.

• Strong Quality Awareness

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