Senior Raw Materials Quality Consultant, GMP & Lifecycle Management
Overview
Quality leadership role owning the global Raw Materials program for commercial manufacturing. Lead strategic initiatives to qualify, govern, and improve raw materials and consumables across the product lifecycle. Partner with Quality, Manufacturing, Regulatory, and Supply Chain to ensure GMP-aligned processes and robust data integrity. This role combines deep subject matter expertise with cross-functional influence in a growing biopharma environment.
What You'll Do10
- 1Lead and support a strategic initiative to enhance the global Raw Materials Program for commercial manufacturing.
- 2Evaluate existing raw material qualification processes and identify opportunities for procedural improvements.
- 3Revise and improve Raw Materials SOPs to strengthen compliance, clarity, and usability.
- 4Author and implement new SOPs and SOP Forms supporting raw material lifecycle activities.
- 5Develop specifications, quality records, and controlled documents for raw materials and ensure GMP alignment.
- 6Provide SME guidance on qualification activities across the product lifecycle.
- 7Assess and optimize qualification strategies, controls, and ongoing monitoring.
- 8Support material release, disposition, and investigations including root cause analysis.
- 9Collaborate with QC, QA, Manufacturing, Supply Chain, Regulatory, and Technical Operations on material quality initiatives.
- 10Drive timelines and deliverables with minimal oversight and document outcomes.
Requirements10
- 1Bachelor's degree in Chemistry Biology Pharmaceutical Sciences Biochemistry Microbiology Chemical Engineering or related discipline
- 2Minimum of 10 years of Quality Control Raw Materials experience in pharmaceutical biotechnology biologics or life sciences
- 3Extensive experience supporting commercial GMP manufacturing operations
- 4Expertise in raw material and consumables qualification programs across the product lifecycle
- 5Strong knowledge of GMP quality systems data integrity and material release and disposition processes
- 6Experience authoring editing and reviewing GMP quality documents including specifications and SOPs
- 7Experience supporting solid and liquid raw material sampling and testing programs
- 8Ability to lead cross-functional initiatives influence stakeholders and manage timelines
- 9Comfort operating with minimal oversight and focus on risk-based decision making
- 10Interest in contributing to a growing biopharma organization and potential transition to full-time role
Salary Insight
$60 - $90k per year
Location
Required Skills
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