Ethicon Inc., a member of the Johnson & Johnson Family of Companies, is currently recruiting for a Senior Manager, Bioresearch Quality and Compliance (BRQC) to be located in Somerville, NJ.
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 Senior Manager, 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.
• 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 Johnson & Johnson 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 and GLP 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 designated Ethicon Quality Lead to ensure alignment of the BRQC programs with the overall Ethicon Q&C QMS.Qualifications
• A minimum of a Bachelor’s degree is required
• A minimum of 8 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
• Experience working in the Medical Device or Pharmaceutical industry is required
• Experience working in a R&D/Clinical Trials/Clinical QA environment is highly preferred
• 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 and may require up to 20% domestic travelPrimary Location
United States-New Jersey-SomervilleOrganization
Ethicon Inc. (6045)Job Function
Quality (Generalist)Requisition ID