Manager, Regional Franchise Quality, Self-Care

Johnson & Johnson Family of Consumer Companies is recruiting for a Manager, Regional Franchise Quality for Self-Care, located in Fort Washington, PA.Johnson & Johnson Consumer Inc., based in Skillman, N.J., is one of the world's largest consumer health and personal care products company. Our consumer companies produce many of the world's most trusted brands, among them JOHNSON'S® Baby, BAND-AID®, NEUTROGENA®, TYLENOL®, MOTRIN®, and LISTERINE®. Each one of our consumer businesses embraces innovative science to create products that anticipate consumer needs and create experiences that help them live healthy, vibrant lives.This position represents Quality Assurance on project teams for the Self Care franchise and provides vital support including process development, technical transfer support, continued process validation and PAI readiness. This role supports portfolio expansion beyond OTC ingestible products into new platforms to support business growth. Stays engaged in product development and review cycles, and new product launch project information. This position builds positive relationships with R&D, R&D Q&C, Tech Ops, Regulatory Affairs and Project Management on teams. Provides compliance input on project issues. Performs Quality and Compliance review of Development and PAI filings. This is an exciting opportunity to work on the pre-commercialization of pivotal brands! Ready to get started?Key Responsibilities:

Attend GMP training on the schedule designated for my role and as appropriate

Enforce, adhere to and implement strict compliance with procedures applicable to my role.

Exercise the highest level of integrity in the tasks that I perform

In a timely and prompt manner, identify, report and seek correction for deviations noted in my workplace.

Embrace a behavior of employee involvement and dedication to doing the job right the first time

Provide departmental compliance support to Project teams. Lead Project Sub-teams and provide input to resolving compliance issues, as necessary.

Review & Approve Development Reports, and Pre-Approval Inspection (PAI) submissions.

Set strategy and support execution of regional and local process improvements and P&L driven projects

Provide Technical Compliance Review and approval for process development, tech transfer planning and assessment, raw material specification approvals, PAI filings and inspection readiness support.

Acquisition and divestiture execution and support

QualificationsEducation:

Bachelor’s degree in a Science Field is

required. Advanced Degree is preferred.

Required:

A minimum of 5 years

working in the pharmaceutical, medical device, consumer and/or DSHEA

industry is required.

An understanding of Drug

GMPs, supplement GMPs, Medical Device, New Drug Development process,

Technical Transfer, and Process Validation is required.

Technical problem-solving

skills are required

Knowledge of applicable

Federal Regulations and Guidelines (i.e. CFR Parts 210 & 211, ICH Q7A,

Guidelines for process Validation, Scale-Up and Post Approval changes

{SUPAC} etc. are required

Preferred:

Previous experience in

Quality Assurance is preferred.

GMP audit experience is

helpful.

Knowledge of statistical

tools/methodology, analytical and/or microbiological techniques, method

validation, and transfer preferred

Experience with

acquisitions and divestitures preferred

Sterile manufacturing

experience preferred

Ability to empower, lead,

supervise and partner with people to accomplish project work objectives is

preferred.

Other:

This position will be

located Fort Washington, PA and may require up to 15%

domestic & international travel

Johnson & Johnson is an Affirmative Action and Equal

Opportunity Employer. All qualified applicants will receive consideration for

employment without regard to race, color, religion, sex, sexual orientation,

gender identity, age, national origin, or protected veteran status and will not

be discriminated against on the basis of disability.Primary LocationUnited States-Pennsylvania-Fort Washington-OrganizationJohnson & Johnson Consumer Inc. (6101)Job FunctionQualityRequisition ID9071200728