Johnson & Johnson Careers
Sr Director, BioResearch Quality & Compliance, Consumer
Requisition ID: 7710180330
- Global establishment and alignment of BRQ policies, standards and procedures across all regions and franchises in Consumer.
- Implementing a Clinical / Preclinical Quality Management System (QMS) that not only fits in seamlessly with JNJ Enterprise strategies and policies but also matches the development of the industry and regulatory demands for clinical and preclinical regulations.
- Collaborating with Business Quality to ensure monitoring of bioresearch activities is integrated in the Consumer Quality Management System.
- Member of the Consumer Q&C Management Team and the BRQC Senior Leadership Team.
- In coordination with the shared service groups for Quality Assurance and Quality Processes, delivers a global Quality and Compliance program across Consumer for Good Clinical Practice (GCP), Good Laboratory practice (GLP) and Safety Vigilance.
- Providing strategic leadership to members of BioResearch Quality organization.
- Global spokesperson and negotiator with regulatory health authorities for Consumer Bioresearch inspections.
- Play a strong role in influencing the external regulatory and industry environment
- Leading the BioResearch Quality management review at appropriate boards in Consumer.
- Ensuring Senior sector based Management are advised of critical compliance issues.
- Driving processes, systems and metrics that will lead the organization towards a more proactive model of quality & compliance.
- Responsible for establishing and maintaining effective business partner relationships across Consumer and J&J.
- Building strong, diverse teams with deep succession plans.
- A minimum of a Bachelor’s degree is required. An advance degree is preferred.
- A minimum of 10 years of experience working in either Pharmaceutical, Consumer and or Medical Device industry is required.
- A minimum of 8 yrs deep GCP and medical safety Quality expertise is required.
- A comprehensive knowledge of worldwide Clinical, Preclinical and Safety compliance regulations and guidelines, for various regulatory classifications of products is required.
- Experience with Health Authorities is preferred.
- Experience with associated compliance systems such as; ISO and HCC is preferred.
- Previous experience managing a professional staff is required.
- A minimum of 20% domestic and international travel is required based upon business needs
United States-New Jersey-Skillman
North America-United States-New Jersey-New Brunswick
J & J Consumer Inc. (6101)