Johnson & Johnson Careers

Manager, Document Management

West Chester, Pennsylvania
Quality Systems


Job Description

Requisition ID: 6278190201

DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, is recruiting for a Manager, Document Management, to be located in West Chester, PA.

 

DePuy Synthes provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

 

The Manager, Document Management, will be responsible for managing the Document Management department in West Chester.

  • Responsible for content of all local document management procedures (non-manufacturing), ensuring compliance with applicable standards and regulations.
  • Represent Synthes Document Management for revision of PLM System configurations working with internal clients and application administration to ensure business needs are met in a compliant manner.
  • Prioritization of business requests/Change Order processing.
  • Resolve issues and provide guidance to the business with regard to Document and Change Management processes.
  • Promote Document Management processes and role of Document Management department/Change Analysts as key business partners and SMEs.
  • Continuous improvement and harmonization of Document Management procedures across Synthes USA and Synthes Europe, as well as Legacy DePuy and Legacy Synthes, as appropriate.
  • Support and provide guidance to all Synthes-USA Change Analysts (West Chester, Brandywine, Elmira & Monument).
  • Participate in business planning activities (budgets, project and resource planning) as required.
  • Manage Periodic Review activities for Synthes-USA and Synthes multi-site procedures in PLM System.
  • Complete and/or support CAPA, Non-Conformance and Audit Observation activities as needed.
  • Support all audits and inspections (internal and external) as requested, as well as Legal inquiries and holds.
  • Other duties as assigned by management.


Qualifications
  • Minimum of a bachelor’s degree is required
  • Minimum 5 years business experience, including 3 years’ experience with Quality Systems and/or Change Control in a regulated industry is required
  • A minimum of 2 years of people management experience and the ability to set tactical direction to support strategic initiatives is required
  • Experience with electronic Document Management / Product Lifecycle Management Systems is required
  • Experience with MRP/ERP systems is preferred
  • Intimate knowledge of Document Management practices, government reporting and legal matters, departmental budgets and high-level strategic quality initiatives is preferred
  • Experience with authoring and maintaining procedures and work instructions is required
  • Ability to apply Project Management/ Process Excellence skills to obtain necessary results is preferred
  • Strong team-building skills, with the ability to function as a team player or leader on cross-functional teams to obtain necessary results is required
  • Strong time management skills, including the ability to multi-task and prioritize work in a dynamic environment is required
  • This role will be located in West Chester, PA and may require up to 10% domestic and international travel


Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.



Primary Location
United States-Pennsylvania-West Chester-
Organization
Depuy Orthopaedics. Inc. (6029)
Job Function
Quality Systems
Requisition ID
6278190201