Details :
Title : Senior Supply Chain Specialist Change Control Owner
Duration : 12+ months(Extendable)
Location : Santa Monica, CA (Onsite) or any Client site
Position Summary
Everyone at Client is grounded by one common goal curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. We are seeking a highly motivated individual to join our Global Supply Chain (GSC) organization as a Senior Supply Chain Specialist Change Control Owner in the GSC Business Operations team, reporting into the Senior Manager of Supply Chain.
The Senior Specialist will work closely with the GSC organization to own and manage Supply Chain initiated change controls by our Global and Regional Supply Chain teams as well as partner with other Technical Operations functions including Quality, Process Development, and Manufacturing.
Position Responsibilities
Leverages previous applicable experience to become Global Supply Chains subject matter expert on Clients QMS Change Control Management SOPs and application
Owns GSC-initiated change control records and partners with Supply Chain SMEs to define, plan, and implement change control records across all global regions
Maintains record compliance by tracking adherence to key record dates and securing approval for justified extensions
Tracks completion of pre-implementation, implementation, and post-implementation tasks
Communicates record status, risks, and mitigation plans to team members and stakeholders
Maintains change control tracking resource for monthly status reporting
Coordinates change control tasks including scheduling and facilitating stakeholder meetings
Acts as Change Control Management point of contact for GSC project managers
Partners with Quality to ensure change control records follow governing procedures
Utilizes change management principles to support effective adoption and sustainment
Tracks and escalates delays or emerging risks
Identifies and participates in continuous improvement efforts for Change Control and Global Supply Chain
Performs additional responsibilities as the role evolves
Qualifications
Masters Degree with 3+ years of Supply Chain and / or Change Control and / or Operations experience OR
Bachelors Degree with 5+ years of the aforementioned experience OR
Associates Degree with 7+ years of the aforementioned experience OR
High School Diploma / GED with 9+ years of the aforementioned experience
Preferred Qualifications
1+ years experience 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, MS Office
Experience in life sciences such as cell / gene therapy, pharmaceutical, biotech, or medical devices
Demonstrated mastery of change control management methodology
Excellent communication, organization, and multi-tasking abilities
Ability to influence without authority and work cross-functionally
Values-driven, detail-oriented, and committed to continuous improvement
Supply Chain Specialist • Santa Monica, CA, United States