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Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting a Supervisor of Quality Systems Investigations, CAR-T in Raritan, NJ!
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/.
Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our pharmaceutical products? Apply today for this exciting opportunity!
The Senior Supervisor QA Investigations is responsible for supervising the team involved in quality systems support of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.
Key Responsibilities:
- Supervise Quality Systems Investigations Team in training, creating metrics, and procedural updates related to non-conformances, investigations, and Corrective and Preventive Actions (CAPAs) in compliance with regulations and guidance.
- Conduct the Instructor-Lead training (ILT) program for the Nonconformance, CAPA, root cause analysis tools, and writing investigations. Provide and govern metrics and data for the certification program.
- Ensure the On-the-job training (OJT) Certification program for Investigators and QA Reviewers is scheduled and working as intended. Coordinate with the Certification program Coaches and QA Investigation department to properly assign and schedule appropriately.
- Responsible for tracking, trending, and presenting data related to investigations and CAPAs for weekly and monthly Quality assessment metrics.
- Drive alignment and efficiency between local and global processes and update the applicable procedures when required.
- Lead and serve as site process owner for the site's Investigations quality system Comet and Track wise.
- Engage in Raritan site level councils/ team meetings, ensuring the CAR-T site needs are represented
- Ensure and maintain a state of inspection readiness; provide front/ back room support during audits
- Retrieve reports and conduct data analysis to support monitoring of key performance indicators.
- Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements
- Other duties will be assigned, as necessary
Qualifications
Education:
- Minimum of a Bachelor’s Degree in a science and/or teaching background.
Experience and Skills:
Required:
- Minimum 4 years of relevant work experience with Quality Assurance Systems or Quality Assurance Investigations
- Experience with leading on the job trainings or coaching within a quality setting
- Experience with non-conformance/deviations management
- Knowledge of cGMP regulations and FDA/EU guidance
- Excellent written, verbal communication and organizational skills
Preferred:
- Experience in Quality Assurance/ Quality Systems related to cell therapy manufacturing in commercial setting
- Supervisory experience leading projects or training within Quality Assurance
- Experience with Statistical Methods, as well as oversight of KPIs and Metrics in a QA setting
- Experience with TrackWise, Salesforce or equivalent QMS
- Experience with processing documents via document management systems (such as TruVault or equivalent DMS)
Other:
- Requires ability and flexibility to accommodate unplanned overtime (including nights and weekends) on little to no prior notice
- This position is anticipated to have 10% travel
- The salary for this position, if located in the United States, is anticipated to be between $90,000 to $135,000
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)).
- This position is eligible to participate in the Company’s long-term incentive program.
- 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
- Work, Personal and Family Time - up to 40 hours per calendar year
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 .
