Manager External Quality Cell Therapy

Johnson and Johnson Supply Chain is recruiting for a Manager External Quality Cell Therapy! This position can be located in the New Jersey or Pennsylvania area.

At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. As the world's largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.

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

Qualifications

Education:

Minimum of a bachelor's degree in science, Medical or equivalent technical field is required

Experience and Skills:

Required:

• A minimum of eight (8) years of relevant work experience, with proven quality-centric experience (QA/QC) experience within the pharmaceutical, biotech, medical device or healthcare industry.

• Experience leading and owning investigations, CAPAs and/or CAPA actions

• 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 is required

• Proven 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 preferred

• Understanding of Data Analytics to drive performance preferred.

• Solid understanding of quality system applications such as TrackWise and TruVault

Other:

• This position may require up to10% travel.

• The anticipated salary for this position will be between 100,000- 172,500 USD$

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan.

The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits:
Vacation - up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year

Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

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.