1+ months

Senior Manager, Quality Control Laboratory Operations

Johnson & Johnson
Raritan, NJ 08869

Janssen Supply Group, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Manager, Quality Control Laboratory 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 Quality Control Laboratory Operations will be responsible for management of the stability testing operation.

Responsibilities include but are not limited to:

  • 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.
  • Management and oversight of method transfers, including management of ongoing annual & validation stability program, stability testing/trending & report and assurance of appropriate staffing and training.
  • Lead investigations including OOT/OOS, CAPA, quality system metrics for Stability Ops and escalations related to stability as needed.
  • Act as the liaison to internal and external business partners, as well as facilitate health authority and DEA inspections.
  • Perform budgetary planning, manage, and report on the budget status.
  • Maintain up-to-date knowledge of regulatory guidance’s and industry standards related to stability ensuring the lab’s readiness for inspection.
  • Report the status updates for established quality metrics
  • Ensure facilities and equipment are in good condition.
  • Maintain site registrations, as applicable (e.g., FDA and/or DEA). 

  • A minimum of a Bachelor's degree is required, preferably a Bachelor’s degree in Analytical Chemistry. An advanced degree is welcomed.
  • Experience leading direct reports with strong people management skills and collaborating with senior leadership is required.
  • 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.
  • A minimum of 5 years’ experience working as an analytical chemist with expertise in HPLC, UV, IR, Dissolution, pH, kF, etc. 
  • Prefer strong knowledge with instrument qualifications (IQ/OQ/PQ) and other compliance actives required before implement.
  • Strong well-rounded knowledge of all functions within the lab and has performed analytical method transfers is required. 
  • Tested and knowledgeable of various formulations such as: solid oral, liquid, creams, medical devices, nasal, etc. is preferred.
  • Strong knowledge and implementation of operational excellence including elements such as: Lean/six sigma, standard work, 6S, performance management, etc. is strongly preferred.
  • Familiar with analytical lab systems is required (e.g., Empower, LIMS, Investigations, CAPAs, Trackwise, etc.)
  • Demonstrated experience with making sound scientific and business-related decisions is a must.
  • Knowledge of current stability guidelines and industry best practices are required.
  • Excellent written and verbal interpersonal skills are required.
  • This position is located in Raritan, NJ and may require up to 20% domestic 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.

Primary Location
United States-New Jersey-Raritan-
Job Function
Quality Control
Requisition ID
Posted: 2018-11-09 Expires: 2019-01-13

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Senior Manager, Quality Control Laboratory Operations

Johnson & Johnson
Raritan, NJ 08869

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