Advisor - Raw Materials Testing GMP Laboratories

About This Role

This role provides strategic and operational leadership for raw material testing within GMP laboratories, ensuring timely, compliant, and scientifically sound testing to support manufacturing operations. The leader drives continuous improvement, inspection readiness, and cross-functional collaboration to achieve quality objectives. This role is crucial for developing and implementing new systems and business processes in a new pharmaceutical manufacturing and drug development facility.

Responsibilities

• Set the vision and direction for the Raw Material Testing function, aligning with site and global quality strategies
• Develop and execute strategies for capacity planning, resource optimization, and adoption of analytical technologies
• Ensure full adherence to cGMP, global quality standards, and applicable regulatory requirements for raw material testing activities
• Lead internal and external audits, and represent the function during regulatory inspections
• Oversee deviation investigations, CAPA implementation, and uphold data integrity principles (ALCOA+)
• Lead end-to-end raw material testing processes, including sampling, scheduling, execution, data review, and timely release
• Oversee equipment lifecycle management, including installation, qualification, calibration, and preventive maintenance
• Serve as the primary liaison between QC, QA, warehouse, and manufacturing to ensure seamless flow of raw material testing and release
• Lead and develop a team of analysts and scientists, including staffing, training, qualification, coaching, and performance management
• Foster a culture centered on safety, quality, scientific excellence, and continuous learning

Requirements

• Scientific degree (BS/MS/PhD) in Chemistry, Biochemistry, or related discipline
• Ph.D. with 5+ or BS/MS with 10+ years of experience in GMP analytical laboratories with progressive leadership roles
• Extensive experience in raw material sampling, testing and release strategies
• Proficiency in analytical techniques such as chromatography and spectroscopy
• Experience with LIMS, SAP, and quality systems including TrackWise and Veeva

Qualifications

• Scientific degree (BS/MS/PhD) in Chemistry, Biochemistry, or related discipline
• Ph.D. with 5+ or BS/MS with 10+ years of experience in GMP analytical laboratories with progressive leadership roles

Nice to Have

• Experience with Lean/Six Sigma methodologies and continuous improvement approaches
• Strong communication, stakeholder engagement, and cross functional leadership capabilities
• Familiarity with global regulatory requirements and industry audit expectations
• Demonstrated ability to drive and accept change
• Demonstrated success in persuasion, influence, and negotiation
• Ability to prioritize multiple activities and manage ambiguity

Skills

* Required skills

Benefits