Director Quality Assurance Clinical Operations
Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more atEssential tasks and responsibilities:Leading the Operational QA groups in the pilot plants of Beerse, Schaffhausen and Leiden Advanced Therapies to ensure that the GMP activities as manufacturing, packaging and labelling of Investigational Medicinal Product (IMP) can be carried out as required by legislation and ensures quality and compliance of the IMP products.Directly supervises teams that are responsible for Quality Assurance activities for Pilot Plants and for Qualification and Validation. The teams are located in Beerse (BE), Leiden (NL) and Schaffhausen (CH).Main responsibilities:Quality Leadership
Operational Quality Performance
Management of Quality Activities
Management of Inspections
Magnitude and complexity:You are responsible for the QA oversight of 4 separate pilot plants: Pilot manufacturing Beerse, Clinical Packaging & Labeling Beerse, Fill-Finish Pilot plant Schaffhausen and Advanced Therapies Pilot Plant Leiden.You will manage 4 Sr Managers with each additional direct reports. In total, the team consists of 25-30 members, potentially extended with contractors.The type of products that are being produced in these plants are from the AT, LM, SM platforms and can be solid, liquids and sterile products.Not meeting the Q&C requirements for these pilot plants might result in suspension of licenses and GMP certifications and could also potentially jeopardize the execution of the clinical trials.Qualifications
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Beerse, Anvers
Fri, 13 Dec 2024 02:45:09 GMT
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