GMP Quality Systems Specialist

An American biotechnology company that develops cancer immunotherapy products with a primary focus on genetically engineered autologous CAR T cell therapy — a cell-based therapy which relies on chimeric antigen receptors and T cells.

Established in 2000, VARITE is an award-winning minority business enterprise providing global consulting and staffing services to Fortune 1000 companies and government agencies. With 850+ global consultants, VARITE delivers comprehensive scientific, engineering, technical, and non-technical staff augmentation and talent acquisition services.

Location: Santa Monica, CA (Hybrid 3 days onsite) — will transition to El Segundo in 2027
Contract Duration: 12 months
Pay Rate Range: $70.00/hr - $78.77/hr on W2
Work Authorization: Only USC or GC

About the role

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: 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, the Senior Supply Chain Specialist will be based onsite at the client’s Global HQ in Santa Monica, CA or any other client site in the network.

Responsibilities

• Leverages previous applicable experience to become Global Supply Chain’s subject matter expert on the 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 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 or 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.

Requirements

• Master’s Degree with 3+ years of Supply Chain and/or Change Control and/or Operations experience
• Bachelor’s Degree with 5+ years of the aforementioned experience
• Associate’s Degree with 7+ years of the aforementioned experience
• High School Degree / GED with 9+ years of the aforementioned experience

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 an 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.

Benefits

• Health Insurance: Medical, dental, and vision coverage
• Retirement Plans: Participation in a company-sponsored retirement savings plan
• Legal Service Plans: Offering access to attorneys for legal advice and representation