Manager, Annual Drug Product Review and Stability

  • Company: Johnson & Johnson
  • Location: New Jersey, United States
  • Posted: December 21, 2016
  • Reference ID: 4321161216-en-us

Johnson & Johnson Consumer Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Manager, Annual Drug Product Review and Stability to be located in Skillman, NJ.

Johnson & Johnson Family of Companies touches more than a billion people’s lives each day through our health care products and services, our corporate giving, and the volunteer efforts of our employees. The Johnson & Johnson Group of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units:  Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and Over-The-Counter (OTC) products. 

The Manager, Annual Drug Product Review and Stability will:
  • Be responsible for oversight of the Annual Drug Product Review (ADPR)/Annual Product Review (APR) and Marketed Product Stability (MPS) processes
  • Provide overall Quality Assurance leadership in the management of ADPR/APR reports supplied by contract manufacturing sites engaged in the production of NDA, oral ingestible and topical OTC drugs and select combination products for J&J Consumer.
  • Provide overall Quality Assurance leadership in the management of MPS studies at contract manufacturing sites and external contract laboratories for the afore-mentioned products in addition to Class II Formulated Medical Devices, Cosmetics, and Nutritionals.
  • Have direct responsibility for a team of professional employees (Quality Leads and Quality Analysts) and contractors at multiple levels of experience, training, and skills. 
  • Act as the Subject Matter Expert (SME) for Annual Drug Product Reviews/Annual Product Reviews, Marketed Product Stability and quality assurance processes, procedures, and activities. 
  • Document rationales which are technically accurate and regulatory compliance focused for product disposition, risk assessment/mitigation, non-conformances, corrective actions, and internal audit observation responses.
  • Conduct, execute and document thorough investigations and CAPAs for high risk/high complexity issues. 
  • Review and approve compliance records, specifications, procedures, and other documents, as required by procedure. 
  • Lead the development and introduction of new processes and procedures which may impact multiple functions or regions. 
  • Independently interact with senior Quality leadership to negotiate and influence quality decisions.
  • Assume full QA oversight responsibilities for discrepancies and identified issues.
  • Participate in audits of external stability partners to ensure compliance with applicable regulations, Quality Agreements, and contractual requirements.
  • Author Standard Operating Procedures (SOPs) and conduct user training in support of ADPR/APR and MPS processes. 
  • Oversee staff in the use of statistical tools for ongoing trend monitoring and evaluation of External Manufacturing data, and ensure procedures for data receipt/verification and for statistical output interpretation, documentation, and review are followed. 
  • Ensure the creation, dissemination and completion of annual ADPR/APR and MPS schedules/plans.
  • Oversee the maintenance of ADPR/APR and MPS databases. 
  • Review change controls and set associated requirements as applicable.
  • Serve as a core member of the Stability Committee and ADPR/APR Community of Practice.
  • Participate in regulatory/corporate inspections as needed.

  • A minimum of a Bachelor’s degree (or equivalent degree) in a technical field (Chemistry, Engineering, Sciences, Pharmacy or similar disciplines) is required.
  • A Master’s or other advanced degree is preferred.
  • A minimum of 8 years of professional experience in a regulated industry (Pharmaceutical, Medical Device, OTC Drug, Cosmetic, and/or Food and Dietary Supplements Industry) is required.
  • Supervisory experience in a FDA-regulated industry is required.
  • A minimum of 5 years Quality Assurance and/or Quality Control experience is required.
  • A minimum of 2 years’ experience in Quality Control/R&D analytical pharmaceutical or similar regulated industry laboratory is required.  
  • Experience with Out-of-Specification (OOS) and Out-of-Trend (OOT) is required.
  • Strong knowledge of CFR 210, 211, 820, SUPAC, ICH and CAPA is required.
  • Experience in the facilitation of internal/external audits and regulatory inspections is preferred.
  • Experience with Stability programs and Annual Drug Product Reviews is highly preferred.
  • Experience with Minitab, Stat Graphic or other statistical analysis programs is preferred.
  • This position will be located in Skillman, NJ (may require travel to Fort Washington, PA 1 day a week). Position may also require up to 10% additional travel. 

Primary Location
United States-New Jersey-Skillman
J & J Consumer Inc. (6101)
Job Function

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