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
- 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
- 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
- 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.
- 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
- This position will be based in Fort Washington,
PA and maybe require up to 15% travel depending on business needs.
United States-Pennsylvania-Fort WashingtonOrganization
J & J Consumer Inc. (6101)Job Function