Supply Chain Specialist - IV

Our Client, a Biopharmaceutical company, is looking for a Supply Chain Specialist - IV for their Santa Monica, CA/El Segundo, CA/Hybrid location.


Responsibilities:

• Leverages previous applicable experience to become Global Supply Chain's subject matter expert on Kite's QMS Change Control Management SOPs and application.
• Owns GSC initiated change control records and partner with Supply Chain SMEs to define, plan, and implement change control records across all global regions.
• Maintains record compliance by utilizing effective administration and communication resources and/or methods to track quality records for adherence to key record dates and gain approval for any business justified extensions.
• Tracks completion of pre-implementation, implementation, and post-implementation tasks, communicating interdependencies
• Effectively communicates with team members and key stakeholders on a record's status, risks, and mitigation plans.
• Maintains change control tracking resource for monthly status reporting.
• Coordinates change control records' tasks such as scheduling and facilitating meetings with relevant stakeholders.
• Acts as the Change Control Management point of contact for GSC project managers to ensure change control related milestones and tasks are incorporated into project plans and delivered per schedule.
• Partners with Quality to ensure that all change control records are followed through per governing procedures and standards.
• Utilizes change management principles to champion change for effective adoption and post project sustainment of changes introduced.
• Tracks and timely escalates in case of delays / new risks identified for change control records.
• Identifies and actively participates in the development and refinement of continuous improvement opportunities within Change Control and the broader Global Supply Chain.
• Additional responsibilities are expected as the role and functions remit evolve.

• 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 Degree / 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 in relevant technology such as Veeva QMS, Oracle Agile QMS, Trackwise, Smartsheet, MS Project, Visio, PowerPoint and MS Office for efficient project administration and implementation.
• Experience in life sciences industry such as cell/gene therapy, pharmaceutical, biotech, or medical devices is a plus.
• Demonstrated mastery of change control management processes, procedures and methodology.
• Independently motivated and detail oriented with excellent communication skills.
• Excellent organizational skills and ability to multi-task in a exciting environment.
• Collaborative individual, able to influence without authority and engage senior leaders and functional partners proactively.
• Demonstrates respect, focuses on delivering value, and embraces learning and continual improvement.
• Must have biotech pharma experience

• Health Benefits
• Referral Program
• Excellent growth and advancement opportunities