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Quality & Compliance Lead Specialist


Johnson & Johnson Consumer Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality & Compliance Lead Specialist to be based in Skillman or Princeton, 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, and Over-The-Counter (OTC) products.

The Quality & Compliance Lead Specialist will:

  • Maintain processes and controls ensuring that the performance and quality of new and reformulated/re-designed products conform to established standards
  • Ensure product compliance with J&J Worldwide Standard Procedures (WWSPs), U.S. and Global Quality Systems Regulations (QSRs) including 21 CFR 210, 21 CFR 211, 21 CFR Part 11, and 21 CFR 820 and current Good Manufacturing Practices (cGMPs).
  • Support product launches including launches of: cosmetics, OTC, non-NDA and Class I and Class II medical devices.
  • Ensure that business partners are accountable and understand J&J quality system requirements and how they impact product quality and regulatory compliance.
  • Provide input to project teams to ensure strategic compliance and quality requirements are met during product development, scale up and validation.
  • Coordinate new product activities between Business QA, Plant QA and Manufacturing to ensure effective hand-offs and flawless execution of all new product processes and activities, resulting in timely and high-quality documentation for Approval for Product Release (APR).
  • Review and prepare for approval the Development Plan (DP) for new products and product changes requiring an APR or Global Change Control (GCC).
  • Ensure that all work has been conducted according to the DP, established procedures and regulatory requirements.
  • Review and approve GCCs related to labeling change control as required.
  • Provide input to risk assessment on new product quality and compliance related issues.
  • Partner with Internal and External Manufacturing QA and Supplier Quality to ensure that new products and processes are transferred to the manufacturing environment with clear quality plans and robust process capabilities.
  • Partner with Product Development, Technical Transfer and Manufacturing functions to define the product and process Critical-to-Quality (CTQ) / Critical Process Parameters (CPPs) which establish robustness.
  • Partner with the Raw Material Center to ensure that all new raw materials are qualified and suppliers have been approved in accordance with J&J requirements.
  • Represent Business QA at the New Product Innovation (NPI) Reliability SWAT teams to ensure timely execution of new product development initiatives.
  • Represent Business QA at the Technical Review Forums (TRF) to ensure that data from all functions are reviewed by a cross-functional team and that potential concerns are addressed prior to production or commercialization.
  • Represent Business QA at the Regional Stage Gate Committee (RSGC) to ensure that quality and compliance is addressed during the deployment of new product prior to Commit-to-Trade (CTT).
  • Assist in the review of Complaint Vigilance Review Board (CVRB) data in preparation for the CVRB meetings. Highlight any implications to the business identified during the review process.
  • Evaluate emerging trends and regulations and develop communication and implementation plans for new requirements.
  • Provide input to management on product quality and adverse event trends, or single issues which might present safety or compliance risk.
  • Implement new policies, standards and guidance for new technologies, new businesses and emerging regulations.
  • Review product specifications to ensure that design criteria can be met post launch and over the entire shelf life or design life of the product.
  • Ensure that Corrective Action/Preventive Action (CAPA) are initiated, assigned, thoroughly investigated, documented and effectively resolved when deficiencies are found during development, testing, manufacturing and in the APR document.


Qualifications
  • A minimum of a Bachelor’s degree (or equivalent degree) required. A focused degree in the life sciences or engineering is preferred.
  • A minimum of 5 years’ experience in an FDA (or Health Canada)-regulated industry is required
  • Experience and understanding of the following regulations is required: 21 CFR 210, 21 CFR 211, 21 CFR Part 11, 21 CFR 820, and current Good Manufacturing Practices (cGMPs).
  • Experience in Quality Assurance, Quality Systems, or New Product Development in a regulated environment is required.
  • Experience in technical transfer, process development, analytical chemistry, clinical research, microbiology, product safety, product stability and process validation is preferred.
  • Experience in complaint vigilance and complaint reporting is preferred.
  • ASQ and/or Project Management certifications are a plus.
  • This position may require up to 10% travel as business needs dictate and will be based out of the Skillman NJ or the Princeton NJ location.

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.

BE VITAL in your career; Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.



Primary Location
United States-New Jersey-Skillman
Other Locations
North America-United States-New Jersey-Princeton
Organization
J & J Consumer Inc. (6101)
Job Function
Quality (Generalist)
Requisition ID
1232171004