Manager, External Quality Advanced Therapies CAR-T
Johnson and Johnson Supply Chain is recruiting for a Manager, External Quality Advanced Therapies CAR-T .
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. If you have the talent and desire to touch the world, Johnson & Johnson has the career opportunities to help make it happen.
The External Quality Manager is responsible for managing:
· External Apheresis collection partners
· Cell collection Laboratories (that perform Cryopreservation activities) for clinical and commercial CAR-T Products. You 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!
· 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.
· Minimum of a bachelor’s degree in science, Medical or equivalent technical field is required.
· A minimum of 8 years of relevant work experience, with solid quality-centric experience (QA/QC) experience within the pharmaceutical, biotech, medical device or healthcare industry is required.
· 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 is required.
· Critical thinking skills, Excellent written and verbal communication skills with attention to detail is required.
· Demonstrated project leadership experience within regulated quality environment is required.
· 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 ruVault.
· Approximately 50 to 75% travel in EMEA will be required.
· 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.