HireDiversity

Skillman, NJ, US

R&D QA MANAGER-3940120906

Description

Johnson & Johnson Consumer Products Company, a member of Johnson & Johnson's Family of Companies, is recruiting for a Manager, R&D 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®.

This position is responsible for developing and maintaining quality systems and controls that are appropriate, effective, efficient and continuously improving in order to ensure that R&D functions are operating in full compliance with sound scientific practice, Current Good Manufacturing Practices (CGMP), and within Johnson & Johnson policies and standard operating procedures.

Manage the R&D external GMP auditing program. Provide leadership, direction and approval of GMP documentation, including but not limited to, standard operating procedures, batch records, packaging dossiers, protocols, Certificates of Analysis, analytical and microbiology reports, method validation/transfer reports, test methods, specifications, deviations/investigations and R&D Quality Agreements, study materials release, and internal/external auditing.

Responsible for managing a team of individuals that has oversight of the R&D GMP external auditing program along with compliance activities at a site and/or of a functional area. Participate on R&D project teams as the Quality representative. Provide approvals on documentation where applicable (NC/CAPA/CC/Qualifications/Audit Reports/Study Release).Provide Quality guidance on GMP regulatory requirements (including 21CFR Parts 50, 54, 56, 58, 210, 211, 312, 314, 812, 820, and Annex 13), including training of R&D personnel. Responsible for developing and maintaining, along with the execution of integrated and comprehensive quality systems and controls that are appropriate, effective, efficient and continuously improving.

Qualifications


Minimum of BS Degree in Chemistry, Biology, Engineering, or related science is required. A minimum of ten years experience in pharmaceutical, consumer products or FDA Regulated environment is required. A minimum of four years quality assurance and/or research quality assurance experience is required. External auditing experience is required. Prior experience in the Quality release and disposition of Clinical Supplies is required.

A thorough knowledge of GMP regulations as they apply to Drugs and Medical Devices is required. Relevant experience with laboratory and manufacturing functions along with GMP quality assurance functions is required. Prior management of direct reports is preferred.

This position requires the ability to work and make decisions independently and on multiple projects, flexibility to adapt to changing priorities, as well as strong interpersonal and communication skills (including both written and oral). The ability to express regulatory requirements clearly and understandably, and the ability to switch priorities quickly to support business needs while maintaining focus on tactical initiatives is required. The ability to interface and work with a diverse group of departments and individuals is required.

This position will be based in Skillman, NJ and will require up to 30 % domestic and international travel.

Primary Location:North America-United States-New Jersey-Skillman
Organization: Johnson & Johnson Consumer Inc. (6071)