Manager, Pharmacopeia Compliance and Laboratory Systems Support
Location:
Fort Washington , Pennsylvania
Posted:
February 08, 2017
Reference:
7019170123-en-us

Johnson & Johnson Consumer Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Manager, Pharmacopeia Compliance and Laboratory Systems Support to be based in Fort Washington, PA.

 

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, Pharmacopeia Compliance and Laboratory Systems Support will:

 
  • Be responsible for the strategy and tactics of compliance with all major pharmaceutical compendia (e.g., US, European and British) at the manufacturing sites and Home Office. 
  • Maintain up-to-date knowledge of current and proposed Pharmacopeia requirements. 
  • Work with internal partners (e.g., R&D, Technical Operations, Regulatory Affairs, External Manufacturing and US site Quality Assurance) and external partners (e.g., USP/NF, FDA, and industry groups) to evaluate proposed changes, their impact on US OTC products, and participate in providing feedback. 
  • Manage the overall projects to confirm timely implementation of compendial changes at manufacturing sites and the Home Office. 
  • Perform technical Quality and Compliance review of Change Controls, and submissions to pharmaceutical compendia.
  • Also be responsible for Laboratory Operations Systems support driving harmonization of laboratory processes among the internal plants.  This includes responsibility for contributing and providing feedback to support the alignment and prioritization of a Laboratory Improvement Roadmap, including managing/executing the projects on the roadmap to improve the laboratories compliance and efficiencies.
  • Lead or coordinate Enterprise Lab Systems or Technology projects for the J&J Consumer network including identifying opportunities for improvement, best practice sharing and benchmarking in line with the JJSC Labs strategy.
  • Provide proactive input and support to project teams, functional areas and system owners to help ensure quality and regulatory requirements for Laboratory Systems are considered in system purchase or design and implementation.
  • Verify implementation, monitoring effectiveness and reviewing output of tools and techniques to assess, report, and mitigate risks and issues in systems used across the McNeil Laboratories.
  • Serve as source of knowledge for laboratory system quality for functional areas and system owners.
  • Collaborate effectively across areas within McNeil Labs and on IT project teams to help facilitate achievement of quality goals and understanding of and application of appropriate regulations.
  • Assist with educational and training materials and sessions to further develop competencies or understanding across McNeil Labs and partnering IT areas. 


Qualifications
  • A minimum of a Bachelor’s degree (or equivalent degree) in a science, engineering or related discipline is required. 
  • A technical and/or advanced degree or certification (Project Management, Process Excellence, etc.) is preferred.
  • A minimum of 8 years' experience working in a highly regulated industry is required.
  • A minimum of 3 years in Quality Assurance/Quality Control is preferred. 
  • An understanding of laboratory equipment and analytical methods in a Quality Control laboratory is required.
  • An understanding of the compendial review and implementation process for USP/NF or other Pharmacopeia is required. 
  • Employee is required to have a demonstrated knowledge of applicable regulations (e.g., FDA, ICH Q8, 9, 10) including an understanding of computer systems validation methodologies and industry regulations (e.g., 21 CFR Part 11, GAMP).
  • Extensive knowledge of the lab environment as well as previous experience in the use of lab system technologies is required.
  • Prior experience working on a deployment/implementation of laboratory systems is preferred.
  • Prior experience managing cross-functional teams is highly preferred.
  • The ability to partner and influence externally with standard setting bodies (e.g., USP/NF, and other Pharmacopeia), regulatory authorities (e.g., FDA) and industry groups is strongly preferred.
  • Knowledge of statistical tools/methodology, analytical and/or microbiological techniques, method validation, and transfer is preferred. 
  • This position will be based in Fort Washington, PA and maybe require up to 15% travel depending on business needs.


Primary Location
United States-Pennsylvania-Fort Washington
Organization
J & J Consumer Inc. (6101)
Job Function
Quality Assurance

A little about us:
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.

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