- Drives Quality Assurance, Compliance and Technical Support for External Quality contract laboratories (ECLs) within the Pharma R&D organization and Janssen Supply Chain, primarily in the Americas region (North America and Latin America)
- This position serves in teams or major cross-functional project initiatives at the Divisional and the J&J companywide level with regard to management of the external contract labs used globally. Closely works together with other J&J sector leads for external contract labs, Internal JSC-QC Lab representatives, DPDS, Site Quality leads, Product Quality management, Global Quality Lab Systems, Global Procurement and other stakeholders
- Supports the EQ-ECL function Leader in the selection, development and management of External Contract Labs globally
- Responsible for the end-to-end Quality and Compliance oversight of external contract laboratories (ECLs) which will test our Janssen vaccines, for product release and stability purposes, during Emergency use application (EUA) or Commercial stages
- Supports and implements the strategy for continuous improvement of the external contract lab management processes
- Supports the Pharma consolidation plan of external contract labs within DPDS and JSC-QC labs including increased usage of preferred labs
- Support or deputize for EQ-ECL Account Owners responsible for the Vaccines' quality oversight for day-to-day ECL activities, primarily deviation and CPA management. Will support escalations, as required
- Manage all utilized systems to ensure deviations are closed in time for release and stability
- Independently solve issues as well as solving issues with key stakeholders like Subject matter experts from Analytical development, Covid testing team ECL managers, or EQ Account owners for CMOs
- Will partake in the Vaccine program Janssen Q&C initiatives at the ECLs
- Apply cGMP regulations, FDA and international requirements to all aspects of the position.
- Ensure timely and proper reporting to partners and stakeholders
- Position may require flexibility in working schedule on occasion, in order to provide cGMP assistance and quality oversight, namely during key batch testing/release activities
- A minimum of a Bachelor's or equivalent University degree is required, with a focus in engineering, science or an equivalent technical discipline preferred
- A minimum of 4 years experience in Pharmaceutical, Medical Device or Biotech regulated environment (e.g. FDA)
- A minimum of 2 years of experience in Pharma Quality Control or Analytical Development laboratories or closely related experience
- Experience in Quality Assurance, Quality Control and/or Compliance
- Ability to provide cGMP compliance support to ECLs
- Knowledgeable of FDA/EMA regulatory requirements applicable to biologics and/or pharmaceuticals' testing is required
- Ability to independently manage work to meet project objectives and timelines
- Ability to work within cross functional teams with global composition
- Strong interpersonal and written/oral communication skills
- Experience in using Pharmaceutical QMS systems
- Auditing experience
- Ability to build and nurture strong, positive relationships with business leadership
- Proficient in English language (speak, read & write)
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External Quality Contract Laboratories Sr Specialist - South Holland, Nederland - J&J Family of Companies
Beschrijving
External Quality Contract Laboratories Sr Specialist W
Description
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 at
J&J Innovative Medicine is recruiting an External Quality Contract Laboratories Sr Specialist to be located in Europe.
Objectives and Responsibilities
Main Duties/Additional Duties/Sphere of authority
Qualifications
Diversity, Equity & Inclusion at Johnson&Johnson means that "YOU belong"
For more than 130 years, diversity, equity & inclusion 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 every one of our people feels that they belong and can reach their potential. No matter who they are.
Primary Location Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Other Locations Europe/Middle East/Africa-Switzerland-Schaffhausen-Schaffhausen, Europe/Middle East/Africa-Italy-Lazio-Latina, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-France-Haute-de-Seine-Issy Les Moulineaux, Europe/Middle East/Africa-Ireland-Cork-Cork
Organization Janssen-Cilag S.p.A
Job Function Quality Assurance
Req ID: W
