DePuy Synthes Companies of Johnson & Johnson is seeking a World Wide Manager of Document Management, to be located in our West Chester, PA, or Raynham MA, or Warsaw, IN locations.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, more agile and better equipped to meet the needs of today’s evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
Responsible for leadership and oversight of all World Wide DePuy Synthes Document Management. Lead and establish the integration and development of compliant, standardized, and efficient change control business processes for DePuy Synthes.
POSITION DUTIES & RESPONSIBILITIES:
• Perform all job duties in full accordance with the Worldwide Policies on Information Asset Protection, maintain password(s) as Confidential, and protect Critical Business Information.
• Understands, incorporates and complies with all applicable laws and regulations relating to DePuy’s business activities and Policies and Procedures of the Health Care Compliance Program and Code of Conduct.
• Demonstrate a thorough understanding of business partner needs, processes and priorities and manage business partner satisfaction relative to deliverables.
• Act as Document Management Process Owner for DePuy Synthes, including the following: Provide ongoing strategic review and drive continuous improvement of the DePuy Synthes Document Management processes in line with Franchise and Sector standardization initiatives, including implementation of Enterprise standards. Define and implement resourcing strategies to proactively meet emerging business needs. Support the formulation of responses to regulatory agencies in order to address Change Control-related observations. Collaborate in the identification and implementation of corrective actions. Ensure effective and timely completion of all corrective actions.
• Partner with WW Document Management Strategic Manager to drive process integration and harmonization for WW DePuy Synthes through strategic system implementations impacting Product Master Data.
• Partner with the Product Lifecycle Systems Manager to drive PLM system changes to meet emerging business needs.
• Recruit, manage, and develop internal employees and external contractors as required to support business objectives.
• Identify opportunities to leverage resources across the WW DePuy Synthes Document Management community and implement to improve overall efficiencies.
• Participate in the business planning activities (budgets, project and resource planning) as required.
• Bachelor Degree in Information Technology, Engineering, or related technical field required.
• A minimum of 6 years of experience with Quality Systems and Change Control in a regulated industry – Medical Device highly preferred.
• Must have a minimum of 8 years of professional experience.
• Must have experience with Product Lifecycle Management Systems, while MRP/ERP systems experience is highly preferred.
• Ability to interact with, influence, and lead cross-functional, global teams within the DePuy Synthes franchise and across the J&J Medical Devices segment.
• Intermediate MS Office (Excel, Word, Outlook, Powerpoint) skills required.
• Demonstrated knowledge and application of QSR, MDD, ISO 13485 and other international regulations/standards.
• Initiative in innovative approaches to problem solving in a fast paced changing business environment.
• "Out of the box" thinker.
• Strong people and performance management skills for global teams with diverse cultures and business practices.
• Strong verbal and written communications skills for multi-level audiences, including the ability to negotiate win-win solutions to drive standardization is required.
• Strong strategic and tactical planning and execution abilities is required.
• Ability to analyze, balance and prioritize risk.
• Demonstrated knowledge of industry "best practices".
• Independent judgement is required to solve day to day problems, negotiate solutions to business conflicts with multi-level, cross-functional stakeholders. Impact of decisions could result in a significant impact regarding product development or process implementation timelines as well as profitability of WW DePuy Sythes.
• This position will be based in our West Chester, PA, or Raynham MA, or Warsaw, IN locations and requires up to 10% travel.