Ethicon Inc., a member of the Johnson & Johnson Family of Companies, is currently recruiting for a 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 Manager, Bioresearch Quality and Compliance (BRQC) will:
• Provide Quality Assurance (QA) oversight of Clinical and Pre-Clinical Programs.
• Serve as a subject matter expert for Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) and, in general, serve as the GCP/GLP Subject Matter Expert for Clinical/Pre-Clinical R&D Project Teams.
• Conducts audits and assessments of clinical investigational sites, clinical research organizations, institutional review boards (as appropriate), and pre-clinical sites, including ensuring the effectiveness of their Quality Assurance Unit.
• Conducts internal audits of Clinical/Pre-Clinical R&D, including study documentation, e.g. Clinical Study Reports, Trial Master Files.
• 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.
• Collaborate with Clinical/Pre-Clinical R&D to ensure that investigational sites, CRO’s and internal organizations are ready for third party inspections.
• Report to and work in close collaboration with the Senior Manager, BRQC Ethicon to develop and implement effective GCP and GLP quality programs across the Ethicon Franchise.
• A minimum of a Bachelor’s degree is required
• A minimum of 6 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 with and influence project teams
• This position will be located in Somerville, NJ and may require up to 20% domestic travel
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J2W: LI NAPrimary Location
United States-New Jersey-SomervilleOrganization
Ethicon Inc. (6045)Job Function
Quality (Generalist)Requisition ID