Lenti Investigations, Senior Supervisor
About The Position
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 jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. This position is based in Raritan New Jersey. The Senior Supervisor oversees day-to-day investigations activities for the LVV manufacturing process, ensuring GMP compliance, accuracy and timeliness of quality records. The Senior Supervisor carries out duties in compliance with all local, state and federal regulations and guidelines (including FDA, EPA, and OSHA) as well as all company and site policies and procedures.
Requirements
- Strong knowledge of Lentiviral vector/ cell/gene therapy processing.
- Experience with ICH Q7 and/or 21 CFR parts 210, 211, 600, 601, and 610.
- Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint).
- Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) related to Lenti operations and ability to identify/remediate gaps in processes or systems is required.
- Detailed knowledge of compendial (USP, EP, JP, etc.) requirements and standards for manufacturing.
- Ability to accommodate shift schedule. Shifts include routine weekend and evening work as required by the manufacturing process.
- Ability to accommodate unplanned overtime (including nights and weekends).
- A Bachelor’s degree with 4 years of deviation investigations experience and a minimum of two (2) years related supervisory experience is required.
Nice To Haves
- A master’s degree is preferred.
Responsibilities
- Carry out supervisory responsibilities in accordance with the organization’s policies and applicable laws.
- Interviewing, hiring, training employees, appraising performance, rewarding and disciplining employees, addressing complaints and resolving conflict.
- Manage quality system metrics for deviations.
- Evaluate, track, and trend deviations.
- Accountable for reporting of deviation metrics at site and cross-site levels.
- Support internal and external audits.
- Guides daily work activities of 10-15 direct reports within the investigations organization under LV operations.
- Work with Process Development team, Quality and Operations organization to successfully transfer process to cGMP facility to manufacture products.
- Review/approve documents as an investigations department subject matter expert (SME).
- Support investigation of nonconformances, CAPAs and change controls.
- Set priorities and manage work assignments.
- Maintain individual and investigation team training completion in a compliant state.
- Communicate both within team and across departments.
- Foster a culture of compliance and strong environmental, health, and safety performance.
- Promote a mindset of continuous improvement, problem solving, and prevention.
Benefits
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
- Caregiver Leave – 10 days
- Volunteer Leave – 4 days
- Military Spouse Time-Off – 80 hours
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What This Job Offers
Job Type
Full-time
Career Level
Senior
