MANAGER CHANGE CONTROL(Job Number: 1300727)
Principle Objectives of Position: Participate in the management and continuous improvement of the GMS Change Control process, tools and tracking systems. Serve as a member of the Global Quality Systems team, providing customer-based (e.g. GMS sites, GMS and R&D functional areas) focus in the areas of:
- Guidance on headquarters Quality and GMP policies and expectations
- Develop headquarters GMP Policies, Directives, and SOPs
- Implementation of a GMP Policy and Directive framework and governance structure
- Support for strategic initiatives
- GMS Manufacturing and Testing Standard change control Major Duties and Responsibilities: 1. Change Control Program: participate in the GMS Change Control process and GMS TrackWise change control workflows as a Global Quality Systems representative. Participate in process and system improvements under the direction of the Associate Director, Change Control and/or Director, Global Quality Systems. 2. Global Testing Standards: participate in the management of specifications and methods within the GTS system as a Global Quality Systems/GTS representative. Participate in GTS process and system improvements. 3. Serve as a Global Gatekeeper on Change Review Boards. 4. Policies and Directives: Research and provide input on applicable regulations, train and ensure consistency among document authors, manage global review and approval process, manage change impact assessments, issue notifications and training for approved global documents with input from process owners. 5. HQ SOPs: Research and provide input on applicable regulations, manage review and approval process, serve as an approver (as needed). 6. Assist with the implementation of global processes in support of strategic initiatives related to the Change Control program or related processes. May include process mapping, impact analysis, training and implementation support. 7. Perform other duties as assigned.
Education: Minimum of a Bachelor’s degree and 6 – 8 years experience in the Pharmaceutical industry or related field. Skills / Knowledge Desired:
- Strong verbal and written communication skills.
- Meeting facilitation and project management skills.
- Cross-functional experience in one or more areas (i.e. research, analytical/QC, QA, engineering, manufacturing, CMC, IT, etc.).
- Subject matter expertise in Health Authority regulations and practical experience applying regulations in change control, specifications/methods/compendia, validation, packaging/labeling and/or quality assurance.
- Knowledge of compendia, CGMP requirements, FDA regulations and/or engineering standards and the ability to interpret and apply them.
- MS Office experience is required.
- Process mapping and change management experience is preferred.
- Experience with TrackWise is preferred. Capabilities:
- Proven ability to understand complex processes/problems and propose alternate solutions.
- Ability to identify, manage, and/or escalate issues and risks to project timelines.
- Ability to influence, initiate, and manage change.
- Organization awareness and ability to work well cross-functionally.
- Demonstrates the BMS BioPharma behaviors.
Job Function: Quality
Primary Location: NA-US-NJ-New Brunswick
: Tech Op - CNJ - Worldwide Quality & Compliance
- 3 years ago - save job