Sr Manager QA-Clinical Supply Chain.

Job content

Within Janssen R&D, a member of Johnson & Johnson’s Family of Companies, we are recruiting a QA-Clinical Supply Chain Senior Manager, based in Europe (Switzerland or Belgium).

In the Janssen Research & Development area we develop treatments that improve the health and lifestyles of people worldwide. R&D development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, pulmonary hypertension and reproductive medicine.

Our department QA-CSC is responsible for the release and certification of Investigational Medicinal Products used in worldwide clinical trials guaranteeing product quality and compliance with applicable regulations.

As QA-CSC Senior Manager, you will take ownership for the quality oversight and timely release of bulk medicinal product (Chemical and Biological compounds) manufactured at the Drug Product Pilot Plant of CSC in Beerse (Belgium), Fill Finish Pilot Plant of CSC in Schaffhausen (Switzerland) and its external network.

Quality Leadership

• Leads global Drug Product Quality team by supporting, coaching, mentoring and developing team members in reaching quality, business and personal objectives
• Establishes and maintains strong working relationships with business and quality partners to ensure alignment of objectives and results
• Proactively and continuously challenge the organizational performance and develop and implement improvements in organizational performance

Operational Quality Performance

• Serves as the Quality Point of Contact for Drug Product Clinical Supply Chain in Schaffhausen and Beerse, including Biological and Chemical compounds.
• Biological activities are focused on Fill Finish. Chemical compounds include solid, liquid and sterile formulations for use in clinical trials as well as sterilization of API for commercial use.
• Serves as Quality Point of Contact for other Quality teams as well as for DPDS and represents as such the Qualified Person for Clinical Trial Material
• Responsible for the timely release of Clinical Trial Material as well as excipients, packaging materials, medical devices components, combination products and ancillary supplies, all in compliance with regulatory as well as internal requirements. Acting as delegate for the Qualified Person for Clinical Trial Material.
• Close collaboration with External Quality with regard to release of Clinical Trial Material manufactured and/or tested at a contract manufacturing organization
• Handles investigations, CAPAs and Change Controls related to the Pilot Plants as well as contract manufacturing organizations. Ensures Quality and Compliance operational targets are met
• Reviews and approves procedures and production related GMP documents such as batch records, investigations, etc
• Guarantees and maintains quality oversight via periodic Quality Reviews such as Quality System Management Review and Product Review. This includes follow-up and influencing of critical Quality metric.
• Serves as champion for Quality requirements in the manufacturing area for Clinical Trial Material
• Applies Quality Risk Management tools in support of smart development
• Supports and acts as host/spokesperson during Health Authority inspections and customer audits
• Remains current in knowledge, skills and industry trends in the clinical supply area
• With focus on Quality activities, develop and cultivate an environment of innovative thinking through e.g. benchmarking, training, participating in industry forums
• Reports Quality trends and makes a positive contribution by making suggestions for improvement. Ensures defined Quality and Compliance improvements are implemented

Qualifications

• University degree, scientific orientation (pharmaceutical, chemical or biological sciences).
• 8-10 years’ experience in pharmaceutical industry (production environment, product development)
• Ability to provide strategic leadership to meet business objectives and a highly dynamic business environment
• Ability to work in a global environment and lead a global team
• People leadership skills, preferably experienced team leader
• Production related expertise required
• Experience in product development
• Ability to quickly assimilate new technologies, perform risk assessment and develop action plans
• In-depth knowledge in cGMP (domestic & international), ICH guidelines, policies, standards and procedures
• Experience with Quality Systems
• Experience with regulatory inspections and preparedness
• Proven track record to work across organizational boundaries through influencing, negotiation and partnering. Communication and presentation skills across all levels are important
• Understands the business implications regarding quality positions and decisions

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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.

Primary Location
Belgium-Antwerp-Beerse-
Other Locations
Europe/Middle East/Africa-Switzerland-Schaffhausen-Schaffhausen
Organization
Janssen Pharmaceutica N.V. (7555)
Job Function
R&D
Requisition ID
00001HI5