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.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Supply Group, LLC, is part of the Janssen Pharmaceutical Companies.
The Senior Manager Quality Control Laboratory Operations will be responsible for management of the stability testing operation.
? 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 preferred.
? 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., is required.
? Strong knowledge with instrument qualifications (IQ/OQ/PQ) and other compliance activities preferred.
? Strong, well-rounded knowledge of all functions within the lab and experience performing 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.) is preferred.
? Demonstrated experience with making sound scientific and business-related decisions is required.
? Knowledge of current stability guidelines and industry best practices are required.
? Excellent written and verbal interpersonal skills are required.
? This position is located in Titusville, NJ and may require up to 20% domestic travel as business demands.
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 based on disability.