Global Quality Specialist
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Job Location:
Gaithersburg, MD - USA
Monthly Salary:
Not Disclosed
Posted on:
4 hours ago
Vacancies:
1 Vacancy
Job Summary
Description:
MAX bill Rate: $80
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 AZ 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 AstraZenecas Cell Therapy division we follow the science to explore and innovate. We are working towards treating preventing modifying and even curing some of the worlds 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 GCP/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.
Technical Skills:
Proficiency in change control deviation/CAPA document control and training effectiveness.
Ability to translate temperature-controlled cell therapy logistics requirements into clear SOPs/WIs and vendor instructions.
Expertise with eQMS/EDMS and process mapping tools (e.g. Visio/BPMN); strong MS Excel/PowerPoint.
Core Competencies:
Precise technical writing; strong attention to detail and version discipline.
Stakeholder influence across Operations Process Development Quality and external partners.
Structured problem solving prioritization and multi-tasking across concurrent change records.
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 AZ 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 AstraZenecas Cell Therapy division we follow the science to explore and innovate. We are working towards treating preventing modifying and even curing some of the worlds 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 GCP/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.
Technical Skills:
Proficiency in change control deviation/CAPA document control and training effectiveness.
Ability to translate temperature-controlled cell therapy logistics requirements into clear SOPs/WIs and vendor instructions.
Expertise with eQMS/EDMS and process mapping tools (e.g. Visio/BPMN); strong MS Excel/PowerPoint.
Core Competencies:
Precise technical writing; strong attention to detail and version discipline.
Stakeholder influence across Operations Process Development Quality and external partners.
Structured problem solving prioritization and multi-tasking across concurrent change records.
Additional Details
- Managers Requested Bill Rate : 80.00
- Does the position allow for the worker to be virtual/remote : Yes more than 50%
- Critical Position : No
- Career Level : D
- External Job Title : Manager/Specialist Logistics Change Management
Key Skills
- Quality Assurance
- FDA Regulations
- Data Collection
- Food Safety Experience
- ISO 9001
- Mobile Devices
- Root cause Analysis
- Quality Systems
- OSHA
- Food Processing
- Quality Management
- cGMP
