Manager, Change Control
Participate in the management and continuous improvement of the GMS Global Change Control process, tools, and tracking/monitoring systems. Serve as a member of the Global Quality Systems team, providing customer-based support to GMS sites, and GMS & R&D functional areas.
- Develop Change Control Policies, Directives, SOP's, Work Instructions, User Manuals, Forms, Tools and Templates
- Support strategic change control initiatives
- Support daily change control activities to enable business continuity and avoid supply disruptions
- Participate in the GMS Change Control process and GMS TrackWise change control workflows as the 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.
- Assist with the implementation of global process improvements for strategic initiatives related to the Change Control Program ore related processes, which may include process mapping, impact analysis, training and implementation support.
- Serve as the Global Gatekeeper on Change Review Boards to ensure changes meet readiness criteria for board review and approval.
- Review change proposals and work on complex issues requiring significant analysis, evaluation, alignment with SME's and key stakeholders.
- Negotiate and facilitate resolution of ongoing change control issues prior to changes being brought for approval.
- Maintain departmental SharePoint site to ensure information is current
- Generate and perform data analysis for change control metrics
- Minimum of a Bachelor's degree
- 6-8 years' experience in the Biopharm/Pharmaceutical industry with cross-functional experience in one or more areas (i.e. research, analytical, quality, engineering, manufacturing, regulatory CMC, or IT).
- 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 analytical and the ability to interpret and apply them.
- MS Office experience is required.
- Process mapping and change management experience is preferred.
- Experience with TrackWise
- Ability to set priorities and deliver results without constant feedback/input from manager (required based on level of responsibility).
- Proven ability to understand complex processes/problems and propose alternate solutions (required based on need to design and implement global business processes and policies, which requires critical thinking and analysis skills).
- Ability to identify, manage, and/or escalate issues and risks to timelines (required based on time-sensitive nature of assignments).
- Customer and partner focus, including the ability to listen to and incorporate feedback (as appropriate) from key stakeholders (required to ensure completeness and robustness of processes and ensures effective adoption of processes).
- Ability to influence, initiate, and manage change.
- Organization awareness and ability to work well cross-functionally with R&D, Regulatory Affairs, Global Engineering, etc. (required as these are key stakeholders and partners in the development and implementation of global processes and policies).
Demonstrates the BMS BioPharma behaviors.