Sr. Manufacturing Compliance Specialist
About The Position
The Manufacturing Compliance Specialist serves as the compliance subject matter expert within Manufacturing, ensuring cell therapy operations are executed in accordance with current Good Manufacturing Practices (cGMP), regulatory requirements, and internal quality systems. This position partners closely with Manufacturing, Quality Assurance, Quality Control, Process Analytical and Development, Engineering, Validation, and Supply Chain to investigate manufacturing events, implement process improvements, and support reliable, inspection-ready manufacturing operations. This role requires strong Quality Management System (QMS) expertise, the ability to lead cross-functional initiatives without direct authority, and a solid technical understanding of cell therapy manufacturing processes.
Requirements
- BA/BS in a scientific discipline or equivalent experience preferred
- 3-6 years of experience in a biopharmaceutical manufacturing environment
- Familiarity with computer systems such as OpCenter, ERP, EBR, TrackWise and Veeva.
- Must be familiar with biopharmaceutical equipment and manufacturing systems
- Strong Knowledge of Current Good Manufacturing Practices and regulatory requirements
- Excellent communication skills, written and verbal
- Demonstrated experience leading cross functional projects
Nice To Haves
- Lean Six Sigma Certification or Experience
- Root Cause Analysis, GEMBA Problem Solving or equivalent certification or experience
- Experience with Human Error Prevention Programs (HEPP)
- Basic laboratory skills, including working with mammalian cell culture
- Experience in cell therapy or aseptic manufacturing
Responsibilities
- Lead deviation investigations using structured root cause analysis
- Author and manage deviations, CAPAs, and Change Controls through closure
- Perform impact and risk assessments to support manufacturing changes
- Ensure compliance with cGMP requirements, data integrity principals (ALCOA+) and internal quality systems
- Support regulatory inspection readiness and audit responses
- Provide technical support and troubleshooting for cell therapy manufacturing processes
- Author and revise manufacturing documentation (e.g. SOPs, batch records, job aids…)
- Support manufacturing projects, process validation
- Review manufacturing operations to identify compliance and process improvement opportunities
- Maintain expertise in aseptic processing, cleanroom operations, and BSC practices
- Lead cross functional projects and drive initiatives to completion without direct authority
- Partner with CFT (e.g. Manufacturing, Quality, QC, Engineering, Development teams…) to resolve technical and compliance issues
- Drive project timelines, identify risks, and communicate status to stakeholders
- Support Lean and Continuous Improvement initiatives to enhance quality and operational performance
- Support implementation and enhancements of manufacturing systems to include EBR, MES, ERP and electronic QMS
Benefits
- Bonus, incentive pay, equity and benefits may be provided in addition to the base compensation listed above.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
