Strategic Collaboration Change Control Manager

The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services. 

This Manager will play an important role in managing a team to execute the change control processes between J&J Medical Device (JJMD) companies (currently within the Ethicon Endo Surgery, DePuy, and Synthes Quality Management Systems) and our Strategic Collaborator(s) to ensure compliance to the regulations and the Quality Agreement requirements.
Key Responsibilities:
• Own change control processes related to JJMD change control oversight of Strategic Collaborator’s changes, including:
• Change control procedures
• Approval matrices
• Product Lifecycle Management (PLM) system configurations
• Own process for managing Strategic Collaborator’s restricted access in JJMD PLM systems
• Manage any assessment and reporting activities relating to Strategic Collaborator’s change control process
• Manage coordination of changes between JJMD and Strategic Collaborator
• Manage Strategic Collaborator-related change control metrics (cycle time, oversight checker failures, etc.) and associated management reporting, including development of recommended changes to the Strategic Collaborator operating model
• Manage, lead, and identify change control process improvements in partnership with Strategic Collaborator, including any identification of budgetary needs
• Identify and evaluate impacts of evolving JJMD processes and technology on JJMD and Strategic Collaborator change control processes
• Lead or support future projects to expand the Strategic Collaborator model in JJMD
• Act as primary contact for both internal and external audits, as well as quality events, relating to Strategic Collaborator change control processes
• Ensure all activities for self and team are in compliance with the documented quality system and current regulatory requirements
• Communicate job expectations and development opportunities to staff through written performance expectations, manage performance using J&J tools and regular 1:1 interactions, and evaluate each individual’s performance through written performance reviews.
• Ensure staff is adequately trained and that training is completed and documented per company procedures.
• Prepare expense and capital budgets for areas of responsibility and manage budgets within approved plans.
• Participate in business planning activities (budgets, project and resource planning) as required.

Required Experience and Skills:
• Able to recognize and quickly adjust to the need for attention to detail versus big picture thinking
• Able to work in an open office environment
• Able to work remotely with virtual teams
• Able to negotiate competing priorities with key stakeholders
• Able to organize, prioritize, and handle multiple projects simultaneously
• Able to work independently and prioritize with little supervision.
• Strong written and oral communication and interpersonal skills
• Able to lead (and guide others to lead) projects to identify root cause of problematic situations, define solutions, and drive resolutions
• Proficient in Microsoft Outlook, Word, Excel, and PowerPoint
• Proficient in change control processes and Product Lifecycle Management systems (PLM)
• Able to adjust to a dynamic environment and execute evolving Strategic Collaborator strategies
• Able to partner with internal and external (Strategic Collaborator) stakeholders to understand their business needs and translate their needs into solutions
• Less than 10% domestic/international travel
• Able to accommodate occasional extended working hours (within local legal requirements)
• Excellent knowledge of English language (C1 or native speaker)

Preferred Experience and Skills:
• Experience with Agile e6, ADAPTIV (Enovia platform), and/or Windchill PLM applications
• Basic understanding of German, French, and/or Spanish