Supply Chain Specialist IV

About the role

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, and partner with other Technical Operations functions: Quality, Process Development, and Manufacturing. These partnerships ensure that GSC owned change controls meet and/or exceed Quality Management System requirements, meet compliance requirements, and are implemented flawlessly per established timelines. The role is based onsite at the Global HQ in Santa Monica, CA or any other site in the network to foster deep partnerships with stakeholders and continued professional growth.

Responsibilities

• Leverage previous applicable experience to become Global Supply Chain’s subject matter expert on 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 control records across all global regions.
• Maintain record compliance by utilizing effective administration and communication resources/methods to track quality records for adherence to key record dates and gain approval for any business-justified extensions.
• Track completion of pre-implementation, implementation, and post-implementation tasks, communicating interdependencies.
• Effectively communicate with team members and key stakeholders on record status, risks, and mitigation plans.
• Maintain a change control tracking resource for monthly status reporting.
• Coordinate change control record tasks such as scheduling and facilitating meetings with relevant stakeholders.
• Act 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.
• Partner with Quality to ensure all change control records are followed through per governing procedures and standards.
• Utilize change management principles to champion change for effective adoption and post-project sustainment of changes introduced.
• Track and escalate delays or new risks identified for change control records in a timely manner.
• Identify and actively participate in the development and refinement of continuous improvement opportunities within Change Control and the broader Global Supply Chain.
• Additional responsibilities as the role and function’s remit evolves.

Requirements

• 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.

Qualifications

• 1+ years of 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 the life sciences industry (e.g., 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 skills.
• Excellent organizational skills and ability to multi-task in a dynamic 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.

Pay

$70–$78/hour.