Manager External Quality Advanced Therapies - 2406200682WDescriptionJohnson and Johnson Supply Chain is recruiting for a Manager External Quality Advanced Therapy! This position can be performed remotely anywhere within the United States.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 https://www.jnj.com/.The External Quality Manager is responsible for managing 1) External Apheresis collection partners and, 2) Cell collection Laboratories (that perform Cryopreservation activities) for clinical and commercial CAR-T Products. The manager would be responsible for providing quality oversight, qualification of external sites, and drive global continuous improvement projects. Job duties are performed within a team schedule and collaboration with key partners!Key Responsibilities:
Responsible for quality oversight and qualifying external apheresis and cell collection laboratories/cryopreservation facilities.
Continuously supervise all aspects of site performance and provide direction to site leaders to ensure quality compliance with regulatory requirements.
Coordinate and provide concurrences on deviations, change controls and CAPAs. Develop, implement, and review SOPs for interactions with External Partners
Provide leadership and insights as a member of global project team. Monitor trends, identify issues, recommend, and implement appropriate actions
Exercise strong communication and interpersonal skills, with the ability to work independently and in a team environment, to effectively support supplier relationship/collection sites
Review relevant regulatory documents prior to submission
Perform tasks in a manner consistent with the safety policies, quality systems and cGMP/GTP requirements under limited supervision
Adaptable and flexible for other duties that may be assigned as needed
QualificationsEducation:A Minimum of a bachelor’s degree is required with a focus in science, Medical or equivalent technical field preferred.Experience and Skills:Required:
A minimum of eight (8) years of relevant work experience, with solid quality-centric experience (QA/QC) experience within the pharmaceutical, biotech, medical device or healthcare industry.
Experience leading and owning investigations, CAPAs and/or CAPA action items or deliverables.
Experience providing quality oversight of a pharmaceutical manufacturing, laboratory, or clinical study site.
Critical thinking skills, Excellent written and verbal communication skills with attention to detail.
Demonstrated project leadership experience within regulated quality environment
Preferred:
Lean Six Sigma or other Process Excellence Certification!
Knowledge in clinical quality, cell therapy, or Research & Development
Understanding of Data Analytics to drive performance preferred.
Solid understanding of quality system applications such as TrackWise and TruVault
Other:
Approximately 25% travel will be required.
The anticipated salary for this position will be between 99,000- 197,000 USD$
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.For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.Primary Location NA-US-New Jersey-RaritanOther Locations North AmericaOrganization JANSSEN SUPPLY GROUP, LLC (6046)Travel Yes, 10 % of the TimeJob Function Quality AssuranceReq ID: 2406200682W