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 Chain’s subject matter expert on Client’s 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
Master’s Degree with 3+ years of Supply Chain and / or Change Control and / or Operations experience ORBachelor’s Degree with 5+ years of the aforementioned experience ORAssociate’s Degree with 7+ years of the aforementioned experience ORHigh School Diploma / GED with 9+ years of the aforementioned experiencePreferred Qualifications
1+ years’ experience as a skilled practitioner in GMP Change Control and familiarity with QMS tools2+ years of relevant change control experience, preferably in a GxP environmentProficiency with Veeva QMS, Oracle Agile QMS, Trackwise, Smartsheet, MS Project, Visio, PowerPoint, MS OfficeExperience in life sciences such as cell / gene therapy, pharmaceutical, biotech, or medical devicesDemonstrated mastery of change control management methodologyExcellent communication, organization, and multi-tasking abilitiesAbility to influence without authority and work cross-functionallyValues-driven, detail-oriented, and committed to continuous improvement