External Quality Contract Laboratories Sr Specialist
Il y a 5 mois
J&J Innovative Medicine is recruiting an **External Quality Contract Laboratories Sr Specialist **to be located in Europe.
**Objectives and Responsibilities**
- 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
- 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
**Main Duties/Additional Duties/Sphere of authority**
- 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
- 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
**Qualifications**:
- 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)
**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.
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