Global Quality Specialist

Job Title: Global Quality Specialist
Duration: 6 months
Location: open to remote but if candidate converts, they can sit onsite in Gaithersburg, Santa Monica & Tarzana

Working Hours: normal business hours 9-5


Interview Process:
1 virtual interview if not by an Client site an hour long


Logistics Change Management (Career Level D)
Function: Global Logistics
Location: Gaithersburg MD or Santa Monica / Tarzana CA
Reports to: Director/Senior Manager, Global Logistics

In Client Cell Therapy division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. We have the potential to grow our pipeline and positively impact the lives of patients around the world. We are committed to making a difference and have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs. This role is part of the Cell Therapy Supply Chain team tasked with supporting critical development of supply chain logistics capability and process. We ask that you plan, escalate issues to ensure successful project delivery.
Summary
Owns end-to-end logistics documentation and change control within the QMS. Partners with Logistics Operations and Logistics Process Development teams to translate approved process designs into clear, controlled documents and managed changes. Focuses on authoring, maintaining, and governing SOPs, work instructions, process flows, forms, checklists, and vendor-facing materials (e.g., COPs/CWIs).

Key Responsibilities
Change Control Governance: Lead intake, impact/risk assessment, approvals, implementation tracking, effectiveness checks, and closure for logistics changes; maintain full traceability in the QMS.
Controlled Documentation: Author, revise, and govern SOPs, work instructions, process maps, RACIs, forms, and checklists; manage periodic reviews, version control, and archival.
Vendor Work Instructions: Develop and maintain client-facing COPs/CWIs and related work aids for couriers, depots, packaging, and monitoring providers; ensure alignment with internal SOPs, service agreements, and GDP.
Process Translation: Convert approved process designs into usable documentation without altering process intent; ensure roles, handoffs, and controls are explicit.
Operations Partnership: Capture user feedback from Logistics Operations to keep documents practical and inspection-ready; coordinate document updates tied to operational changes.
Compliance & Audits: Ensure documents and changes comply with GDP and interfaces with Google Cloud Platform/GMP; act as SME for documentation and change control in audits/inspections.
Risk & Controls: Apply risk tools (e.g., FMEA) to documentation changes; embed preventive controls, monitoring, and acceptance criteria in procedures where appropriate.
Training Enablement: Map documents to curricula; develop role-based training content and effectiveness checks in partnership with LMS owners (content ownership only).
Digital Records: Use eQMS/EDMS for change and document lifecycle; maintain metadata and templates; support periodic library audits.

Qualifications
Education: Bachelor's in Supply Chain, Logistics, Life Sciences, Engineering, or related field; advanced degree or certifications (ASQ, APICS/CSCP, PMP) a plus.
Experience:
6 10 years in pharma/biotech logistics or supply chain with strong QMS and document/change control ownership.
Hands-on experience in logistics operations and cold-chain; GMP/GDP required; clinical trial exposure preferred; cell therapy (chain of identity/custody) a plus.
Track record drafting and governing vendor-facing instructions (COPs/CWIs) and aligning them to internal procedures and SLAs.