Job Details

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 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.

To create a deep partnership with stakeholders across the corporation, as well as to foster continued professional growth, we would like the Senior Supply Chain Specialist to be based onsite at the Global HQ in Santa Monica, CA or any other site in the network.

Responsibilities of the Senior Supply Chain Specialist – Change Control Owner include:
* Leverages previous applicable experience to become Global Supply Chains subject matter expert on 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 records 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.

Basic 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 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.

Pay Range: 70-78/hr