Johnson & Johnson Careers
Manager, Quality & Compliance Medical Device Auditing (GCP/PV)
Somerville, New Jersey
Requisition ID: 3671190110
Ethicon Inc., a member of the Johnson & Johnson Family of Companies, is currently recruiting for a Manager, Quality & Compliance Medical Device Auditing (GCP/PV) in the Bioresearch Quality and Compliance (BRQC) group 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.
As the Manager, Quality & Compliance Medical Device Auditing (GCP/PV), you will lead the quality oversight and support of the Ethicon Clinical Programs and Portfolios supported by BRQC medical devices, and develop partnerships with key business partners and stakeholders, and collaborate with the Head, MD BRQC, and other key MD BRQC associates to develop and implement effective GCP/GPvP/GLP quality programs across medical devices. You will identify and manage risk and business needs both internally, and externally that may have an impact on the Quality Management System and define and implement MD BRQC department or division strategies.
As the Manager, Quality & Compliance Medical Device Auditing (GCP/PV) you will:
• Conducts audits and assessments of clinical investigational sites, clinical research organizations, pharmacovigilance quality systems, local operating companies, institutional review boards (as appropriate), including ensuring the effectiveness of their Quality Assurance Units
• Conducts internal and systems audits of Clinical R&D
• Provide Quality Assurance (QA) oversight of the Clinical and Pharmacovigilance Programs
• Serve as a subject matter expert for Good Clinical Practice (GCP), and Good Pharmacovigilance Practice (GPvP), and, in general, serve as the GCP/GPvP Subject Matter Expert for Clinical R&D Project Teams
• Provide pre-clinical/GLP support as needed
• 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 R&D to ensure that investigational sites, CROs pharmacovigilance systems, 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 GPvP 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.
- Experience working in the Medical Device or Pharmaceutical industry is required.
- A thorough understanding and experience with the application of Good Clinical Practice (GCP) is required.
- Experience with the application of Pharmacovigilance (GPvP) is preferred.
- Working experience in auditing in 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 25% travel.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
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-
Ethicon Endo Surgery Inc (6041)