Management Consulting Group · 2 months ago
GILDJP00016641 Senior Supply Chain Specialist (Change Control Owner) Not Avail for w2 ref
Management Consulting Group is focused on curing cancer and is seeking a Senior Supply Chain Specialist – Change Control Owner to join their Global Supply Chain organization. The role involves managing Supply Chain-initiated change controls, ensuring compliance with Quality Management System requirements, and collaborating with various teams to implement changes effectively.
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Responsibilities
Become Global Supply Chain’s subject matter expert on Kite’s QMS Change Control Management SOPs and application
Own GSC-initiated change control records and partner with Supply Chain SMEs to define, plan, and implement change controls across all global regions
Maintain record compliance using effective administration and communication methods to track key record dates and obtain approval for justified extensions
Track completion of pre-implementation, implementation, and post-implementation tasks, communicating interdependencies
Communicate record status, risks, and mitigation plans to team members and key stakeholders
Maintain change control tracking resources for monthly status reporting
Coordinate change control tasks, including scheduling and facilitating meetings with relevant stakeholders
Serve as the Change Control Management point of contact for GSC project managers to ensure milestones and tasks are integrated into project plans and delivered on schedule
Partner with Quality to ensure all change control records follow governing procedures and standards
Apply change management principles to drive effective adoption and sustainment of changes introduced
Track and escalate delays or newly identified risks in a timely manner
Identify and contribute to continuous improvement opportunities within Change Control and the broader Global Supply Chain
Additional responsibilities as the role evolves
Qualification
Required
Master's Degree with 3+ years of Supply Chain and/or Change Control and/or Operations experience; or
Bachelor's Degree with 5+ years of the aforementioned experience; or
Associate's Degree with 7+ years of the aforementioned experience; or
High School Diploma/GED with 9+ years of the aforementioned experience
Preferred
2+ years as a skilled practitioner in GMP Change Control and familiarity with QMS tools
2+ years of relevant change control experience, preferably in a GxP environment
Proficiency with Veeva QMS, Oracle Agile QMS, TrackWise, Smartsheet, MS Project, Visio, PowerPoint, and MS Office
Experience in life sciences (cell/gene therapy, pharmaceutical, biotech, or medical devices) is a plus
Demonstrated mastery of change control management processes, procedures, and methodology
Independently motivated, detail-oriented, with excellent communication and organizational skills
Collaborative, able to influence without authority and proactively engage senior leaders and functional partners
Demonstrates respect, focuses on delivering value, and embraces learning and continuous improvement