Senior Raw Materials Quality Consultant

Job Title:

Senior Raw Materials Quality Consultant

Job Description

The Senior Raw Materials Quality Consultant leads a strategic initiative to enhance and optimize the global Raw Materials Program for commercial manufacturing operations. This role evaluates and improves raw material qualification processes, strengthens quality systems and documentation, and ensures alignment with GMP and regulatory requirements across the full product lifecycle. The consultant provides deep subject matter expertise in raw materials and consumables, driving risk-based, compliant, and efficient practices that support high-quality, safe products.

Responsibilities

+ Lead and support the completion of a strategic initiative focused on improving and enhancing the global Raw Materials Program for commercial manufacturing.

+ Evaluate existing raw material qualification processes and identify opportunities for procedural and operational improvements.

+ Ensure raw material quality systems align with commercial manufacturing and applicable regulatory requirements throughout the product lifecycle.

+ Revise and improve existing Raw Materials Standard Operating Procedures (SOPs) to strengthen compliance, clarity, and usability.

+ Author and implement new SOPs that support raw material lifecycle management and qualification activities.

+ Develop associated SOP Forms (SOPFORMs) and supporting documentation to ensure consistent execution of raw material processes.

+ Author, revise, and review specifications, procedural documents, quality records, and other controlled documentation related to raw materials.

+ Ensure all documentation adheres to GMP, quality system standards, and data integrity requirements.

+ Serve as the subject matter expert for raw material and consumable qualification activities across the product lifecycle.

+ Support the development and refinement of qualification strategies for raw materials used in commercial manufacturing operations.

+ Assess existing qualification programs and provide recommendations to improve efficiency, compliance, and risk mitigation.

+ Establish and refine appropriate controls for material qualification, lifecycle management, and ongoing monitoring.

+ Provide expertise in material release and disposition processes that support commercial manufacturing.

+ Support investigations, assessments, and quality decisions associated with raw materials and consumables, including root cause analysis and corrective actions.

+ Collaborate with Quality Control, Manufacturing, and Supply Chain teams to ensure compliant and effective material management practices.

+ Provide technical guidance on sampling programs for both solid and liquid raw materials.

+ Review and improve raw material testing strategies and programs to ensure robust control while optimizing resource use.

+ Identify opportunities to reduce testing requirements while maintaining compliance, product quality, and patient safety.

+ Support risk-based approaches to raw material testing and qualification, including risk assessment and mitigation strategies.

+ Partner closely with Quality Control, Quality Assurance, Manufacturing, Supply Chain, Regulatory, and Technical Operations teams on raw material quality initiatives.

+ Provide technical leadership and recommendations on raw material quality-related projects and continuous improvement efforts.

+ Support project timelines and drive deliverables to completion with minimal oversight, ensuring milestones are met and outcomes are documented.

Essential Skills

+ Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, Biochemistry, Microbiology, Chemical Engineering, or a related scientific discipline.

+ Minimum of 10 years of Quality Control Raw Materials experience within the pharmaceutical, biotechnology, biologics, or broader life sciences industry.

+ Extensive experience supporting commercial GMP manufacturing operations.

+ Demonstrated expertise in raw material and consumables qualification programs across the product lifecycle.

+ Strong understanding of commercialization and product lifecycle management as it relates to raw material controls and qualification.

+ Significant experience with material release and disposition processes in a GMP environment.

+ Proven experience authoring, editing, and reviewing GMP quality documents, including specifications and procedural records.

+ Strong knowledge of raw material specifications, SOPs, SOP Forms, protocols, reports, and quality system documentation.

+ Experience supporting both solid and liquid raw material sampling and testing programs.

+ Deep familiarity with GMP, quality systems, and data integrity principles as applied to raw materials.

Additional

Skills & Qualifications

+ Experience working in pharmaceutical, biotechnology, biologics, or life sciences organizations undergoing commercialization.

+ Ability to lead cross-functional initiatives and influence stakeholders in Quality Control, Quality Assurance, Manufacturing, Supply Chain, Regulatory, and Technical…