Johnson & Johnson Careers
Director, Bioresearch Quality and Compliance (BRQC)
Requisition ID: 2940190426
Ethicon Inc., a member of the Johnson & Johnson Family of Companies, is currently recruiting for a Director, Bioresearch Quality and Compliance (BRQC) to be located in Somerville, NJ or Cincinnati, OH.
The Ethicon business offers a broad range of products, platforms and technologies-including sutures, hemostasis products, surgical staplers, trocars, energy devices and synthetic mesh devices-that are used in a wide variety of open and minimally invasive surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity. The Ethicon business combines products and services of two market leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and effectiveness of surgery.
The Director, Bioresearch Quality and Compliance (BRQC) will:
- Serve as a subject matter expert for Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) and will be responsible for leading the GCP and GLP quality activities within Ethicon.
- Partner with Ethicon Clinical/Pre-Clinical business partners to identify their BRQC needs for successful execution of their innovation portfolio.
- Execute audits and assessments of clinical investigational sites, clinical research organizations, institutional review boards, and pre-clinical sites, including ensuring the effectiveness of their Quality Assurance Unit.
- Play a key role in implementing a Clinical/Pre-Clinical Quality Management System that not only fits in seamlessly with MD Segments strategies and policies, but also matches the development of the industry and regulatory demands for clinical and pre-clinical regulations.
- Provide independent compliance oversight of the Ethicon Pharmacovigilance (PV) quality system
- Develop and implement the PV audit strategy and operational plan
- Establish routine presentations of compliance trends and metrics to Ethicon business partners and help champion organizational performance and improvement measures to drive the success of clinical and pre-clinical programs.
- Provide Quality Assurance (QA) oversight of GCP and GLP Programs.
- Support Health Authority and J&J Regulatory Compliance Inspections; partner with Ethicon Q&C and the Medical Device Regulatory Compliance organizations to manage and support external inspection and ensure inspection readiness for bioresearch programs.
- Monitor new regulatory legislation or guidelines which have direct impact on Ethicon (and MD) GCP, GLP and PV QMS and practices and develop appropriate BRQC response, as appropriate.
- Report to and work in close collaboration with the Head, MD BRQC and other MD BRQC key associates to develop and implement effective GCP and GLP quality programs across MD.
- Also report on a dotted line basis and work in close collaboration with the VP Q&C for Ethicon to ensure alignment of the BRQC programs with the overall Ethicon Q&C QMS
- Operate with minimal guidance from Supervisor
- Expected to lead and be proactive in the settings of priority to achieve Ethicon BRQC objectives
- Establish business unit strategies and set priorities to achieve goals and objectives for Ethicon BRQC and Omrix PV independent compliance oversight
- Report directly to the Head, MD BRQC and is a member of the MD BRQC Leadership Team
- Report indirectly to the Vice President, Ethicon Quality and Compliance and is a member of the Ethicon Q&C Leadership Team
- Require exemplary relationship building skills and ability to influence without authority
- Interact with senior level business partners including the Ethicon Director of Clinical Operations, Head of Ethicon Clinical/Preclinical R&D and Medical Safety
- Work closely with other MD BRQC Directors and Ethicon Q&C LT members to influence or execute strategies
- Must have demonstrated experience collaborating and communicating with senior levels of leadership
Responsibility for Others:
- Provide direction to a small team of manager-level associates with responsibility for providing quality oversight to and supporting the clinical, pre-clinical and pharmacovigilance respective quality management systems
- Expected to collaborate with and manage project teams within BRQC and cross-functional
- Develop and implement strategies for the Ethicon BRQC team
- A Bachelor’s degree and a minimum of 12 years of business experience is required
- Experience working in a highly regulated industry is required
- A thorough understanding and experience with the application of Good Clinical Practice (GCP) is required. Additional experience in Pharmacovigilance (PV) is a plus
- Experience working in the Medical Device or Pharmaceutical industry is required
- Experience working in Clinical R&D or Clinical QA environment is required
- Broad based technical knowledge and skills in diverse areas of business (ex: R&D, Operations, QA, laboratories, etc.) is preferred
- Ability to effectively negotiate and influence upper management, affiliates and regulatory agencies to ensure that regulatory and business needs are met is preferred
- Prior supervisory/people management experience is preferred
- This position will be located in Somerville, NJ or Cincinnati, OH and may require up to 25% 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.
United States-New Jersey-Somerville-
North America-United States-Ohio-Cincinnati
Ethicon Endo Surgery Inc (6041)