Senior Supply Chain Specialist
2 weeks ago
Join our dynamic Global Supply Chain (GSC) organization as a Senior Supply Chain Specialist - Change Control Lead in the GSC Business Operations team. In this pivotal role, you will report to the Senior Manager of Supply Chain and play a crucial part in driving supply chain initiatives.
As the Change Control Lead, you will collaborate closely with our Global and Regional Supply Chain teams, as well as with other Technical Operations functions such as Quality, Process Development, and Manufacturing. Your efforts will ensure that GSC-driven change controls not only meet but exceed Quality Management System requirements and compliance standards, all while being implemented seamlessly within established timelines.
To foster deep partnerships across the organization and support your professional growth, we are looking for a candidate who can work onsite at Kite's Global HQ in Santa Monica, CA, or any Kite site in our network.
Key Responsibilities:
- Become the subject matter expert on Kite's QMS Change Control Management SOPs and their application within Global Supply Chain.
- Own and manage GSC initiated change control records, collaborating with Supply Chain SMEs to define, plan, and implement these records across all global regions.
- Maintain compliance by effectively administering and communicating to track quality records and secure approvals for justified extensions.
- Monitor progress through pre-implementation, implementation, and post-implementation phases, while communicating interdependencies.
- Provide timely updates on record status, risks, and mitigation plans to team members and stakeholders.
- Prepare monthly status reports around change control tracking resources.
- Schedule and facilitate meetings related to change control records with relevant stakeholders.
- Serve as the Change Control Management point of contact for GSC project managers, ensuring milestones and tasks are integrated into project plans and adhered to.
- Collaborate with Quality to ensure change control records are followed according to governing procedures and standards.
- Champion effective change management principles for the successful adoption and sustainability of introduced changes.
- Proactively identify and escalate delays or risks associated with change control records.
- Participate in the identification and development of continuous improvement opportunities within Change Control and Global Supply Chain operations.
- Additional responsibilities may evolve as the role develops.
Basic Qualifications:
- Master's Degree with 3+ years of Supply Chain, Change Control, 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 Degree/GED with 9+ years of the aforementioned experience.
Preferred Qualifications:
- 1+ years of experience in GMP Change Control and familiarity with QMS tools.
- 2+ years of experience in change control, preferably in a GxP environment.
- Proficiency in relevant technologies like Veeva QMS, Oracle Agile QMS, Trackwise, Smartsheet, MS Project, Visio, PowerPoint, and MS Office for efficient project management.
- Experience in the life sciences industry, including cell/gene therapy, pharmaceuticals, biotech, or medical devices, is advantageous.
- Demonstrated expertise in change control processes and methodologies.
- Self-motivated, detail-oriented, with outstanding communication skills.
- Excellent organizational skills and the ability to juggle multiple tasks in a fast-paced environment.
- A collaborative individual adept at influencing without authority and engaging with senior leaders and functional partners.
- Commitment to respect, delivering value, and embracing continuous improvement.
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