HireDiversity

Skillman, NJ, US

Senior Manager, North America Skincare - Consumer Health Care Franchise, Quality-8051130110

Description

Johnson & Johnson Consumer Products Company, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Manager, North America Skincare - Consumer Health Care Franchise, Quality for its location in Skillman, NJ.

Johnson & Johnson Consumer Group of Companies develops and markets consumer healthcare, baby care, and beauty/skin care products that address the needs of consumers and health care professionals and incorporate the latest innovations. The portfolio includes heritage brands TYLENOL®, MOTRIN®, ZYRTEC®, JOHNSON'S® Baby, BAND-AID® Brand, LISTERINE®, leading skin care brands such as NEUTROGENA®, AVEENO®, CLEAN & CLEAR®, LUBRIDERM® and healthcare products such as NEOSPORIN®, CORTAID®, REMBRANDT® and REACH®.

The Senior Manager, North America Skincare - Consumer Health Care Franchise, Quality will develop, establish and maintain processes and controls ensuring that the performance and quality of new products conform to established standards and are in compliance with J&J Global and Regional policies and procedures, U.S. and Global Quality System Regulations (QSRs) including 21 CFR 210 & 211, 21 CFR 820 and 21 CFR Part 11 and current Good Manufacturing Practices. The products managed include multiple regulatory classifications (cosmetics, OTCs, NDAs and Class I and II Medical Devices). This individual will ensure that cross-functional partners are accountable and understand our quality system requirements and how they impact product quality and our regulatory compliance. He/she will provide guidance and training to the project teams to ensure compliance and quality requirements during product development, scale up and validation.

The Senior Manager, North America Skincare - Consumer Health Care Franchise, Quality will work with cross-functional project team in planning/approving the product development plans for new products and product changes; ensuring compliance against approved development plan, established procedures, and regulatory requirements thru the development and tech transfer processes; ensuring robust Authorization for Product Release documentation, and authorization for product release. This individual will provide risk assessment on new product quality & compliance related issues. He/she will work with cross-functional teams to ensure robust new products by means of capturing appropriate product CTQs and process CpKs during product/process development and appropriate transfers to manufacturing sites. He/she will review product specifications to ensure that design criteria can be met post launch and during the shelf life of the product. This individual will develop robust process for closing open items found in New Product CAPAs. He/she will prepare and escalate 4-Box Escalations for new product-related issues. This individual will ensure all deviations are documented and approved in an APR Exception Report. He/she will work with the raw material center to ensure all new raw materials are qualified and suppliers are approved according to J&J requirements. The Senior Manager, North America Skincare - Consumer Health Care Franchise, Quality coordinates new product activities between Franchise QA and Supply Chain 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 APR. He/she will measure and evaluate performance of the New Product commercialization process.

He/she will represent QA at the New Product Innovation (NPI) Reliability SWAT team to ensure timely execution of new product development initiatives. This individual will be asked to represent QA at Technical Review Forums (TRF) to ensure data from all functions are reviewed by cross functional team and addresses potential concerns prior to production/commercialization. He/she will also represent QA at Innovation Stage Gate Committee (ISGC) to ensure quality and compliance is addressed during the new product deployment process and prior to Commit-to-trade (CTT).

This individual will assist in the review of Supply Chain QA management review data in the preparation for the Franchise Quarterly Management Review. He/she will highlight implications to the business identified during the review process. This individual will ensure incorporation of CAPA and complaint vigilance learning into the new product development process.

The Senior Manager, North America Skincare - Consumer Health Care Franchise, Quality will work with cross-functional team in ensuring assessment of new product launches for impact to malfunction report ability and same-similar product lists. He/she will work with cross-functional teams in driving continuous improvements by establishing processes to incorporate outcomes from NCs, CAPAs, complaints, and other quality systems into existing Risk Assessments.

This individual will establish internal audit program that includes establishing procedures, audit plan, performing audits, and addressing follow-up requirements. He/she will evaluate emerging trends and regulations and develops communication and implementation plans for new requirements. The Senior Manager, North America Skincare - Consumer Health Care Franchise, Quality leads, develops and implements new policies, standards, and guidance for new technologies, new businesses, and emerging regulations.

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Qualifications


A minimum of a Bachelor's Degree in a technical field (Engineering, Sciences or related) is required. An advanced degree is preferred. A minimum of 10 years of experience in the Medical Device industry is required. Experience in the Consumer and/or Pharmaceutical Drug industry is preferred. Experience in New Product Development Quality and Quality Systems is required. Experience in R&D, Process Development, Technical Transfer, Analytical Chemistry, Clinical Research, Microbiology or Product Safety is preferred. Experience with compliant vigilance and/or complaint reporting is required. An individual that is detail oriented as well as having the ability to manage multiple projects at once is required. Having proven success working with diverse groups (R&D, Quality, and Supply Chain) is required. Excellent written and oral communication skills are required.

This position will be based in Skillman, NJ and may require up to 10% travel.

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:North America-United States-New Jersey-Skillman
Organization: Johnson & Johnson Consumer Inc. (6071)
Travel:Yes, 10% of the time