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
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
- 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
- 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
- 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
- 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
- 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.
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.
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.
United States-New Jersey-SkillmanOrganization
J & J Consumer Inc. (6101)Job Function