Johnson & Johnson Careers
Senior Manager, QC Stability Operations
Requisition ID: 1227180511
Janssen Supply Group, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Manager, QC Stability Operations. The position will be based in Raritan, New Jersey.
Janssen Supply Group, LLC is a global organization responsible for producing and supplying medicines to markets around the world. With quality as its primary focus, this group collaborates with Research & Development and Commercial partners to deliver life-changing solutions for patients in need.
The Senior Manager, QC Stability Operations will be responsible for the Project Management of the implementation & set-up of a work cell for a stability program of McNeil Products under JCS US Stability Operations.
Responsibilities include but are not limited to:
- Management and oversight of method transfers, including management of ongoing annual & validation stability program, stability testing/trending & report writing for McNeil products and assurance of appropriate staffing and training.
- Lead program alignment with cGMPs, JSC Global Standards, Environmental, Health & Safety (EHS) requirements, and DEA requirements (if applicable).
- Lead events including OOT/OOS, CAPA, quality system metrics for Stability Ops and escalations related to stability as needed.
- Act as the liaison with McNeil and 3rd party consultants, as well as handle FDA inspections and internal audits.
- Manage budget allocations and perform budget planning exercises and report on quarterly budget updates.
- Manage ongoing stability operations (e.g., program, testing lab, data analysis/trending, report writing, etc.)
- Ensure lean/robust processes are aligned with applicable cGMPs and JSC Global Standards.
- Maintain up-to-date knowledge of regulatory guidance’s and industry standards related to stability, and assure a constant state of inspection readiness as well as establish metrics and Quality Systems Manager review process and report out on global QMR metrics.
- Ensure facilities and equipment are in good condition.
- Maintain site registrations, as applicable (e.g., FDA and/or DEA).
- Conduct escalation meetings, as needed related to stability issues.
- A minimum of a Bachelor's degree is required. Advanced degree preferred.
- A minimum of at least 10 years’ experience in a regulated GMP environment is required.
- Pharmaceutical Industry experience in an analytical cGMP environment is preferred.
- Experience with decision-making authority as it relates to a small molecule drug product Commercial Stability Program is preferred.
- People management skills and strong leadership experience collaborating with senior leaders is required.
- Knowledge of current stability guidelines and industry best practices are required.
- Strong understanding of statistical principles and concepts related to stability, as well as an understanding of validation requirements for Quality Systems, analytical methods, analytical instrumentation and method transfers are preferred.
- Experience managing projects and a budget is preferred.
- Working knowledge of international shipping and drug product importation requirement is highly preferred.
- Experience handling multiple projects, prioritizing and adapting to business needs and understanding of business requirements is preferred.
- Familiar with analytical lab systems is required (e.g., Empower, LIMS, Event/CAPA management, Trackwise, etc.)
- Working knowledge of cGMP requirements, current FDA enforcement issues and current regulatory authority enforcement practices is required.
- Experience in facilitation of internal and external audits and regulatory inspections is required.
- Lean Principles and project management experience is required.
- Excellent written and verbal interpersonal skills are required.
- This position is located in Raritan, NJ and may require up to 20% domestic and international travel as business demands.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-New Jersey-Raritan
JANSSEN SUPPLY GROUP, LLC (6046)