The DePuy Synthes Companies are part of the Johnson & Johnson Family of Companies. We offer the world’s most comprehensive portfolio of orthopaedic and neuro products and services for joint reconstruction, trauma, spine, sports medicine, neuro, cranio-maxillofacial, power tools and biomaterials.
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 Depuy Synthes 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 Director, BRQC Depuy Synthes to develop and implement effective GCP and GLP quality programs across the Depuy Synthes Franchise. Qualifications
• 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
• May require 20% domestic travel
• The preferred location for this position is Warsaw, IN, however the candidate may be located in Raynham MA or Westchester PA as well.
United States-Massachusetts-RaynhamOther Locations
North America-United States-Pennsylvania-West Chester, North America-United States-Indiana-WarsawOrganization
Depuy Orthopaedics. Inc. (6029)Job Function
Quality AssuranceRequisition ID