Senior Manager – Raw Materials

Senior Manager – Raw Materials

Requirements

• BA or B.S. degree in a science discipline required, or comparable experience
• 10+ years of experience in cGMP or cGxP
• Prior experience related to raw material testing
• 5+ years focusing on raw material testing in a pharmaceutical or biotech environment is preferred
• Strong knowledge of cGMP compliance and regulatory requirements related to raw materials
• Ability to work independently as well as in a team-oriented environment
• Effective time management skills
• Must have excellent verbal, written, interpersonal, and organizational and communication skills
• Self-awareness, integrity, authenticity, and a growth/entrepreneurial mindset

Responsibilities

• Develop the Raw Materials testing program and perform/oversee testing of incoming raw materials for quality, identity, purity, and contamination, ensuring compliance with GMP standards
• Develop, revise, and implement SOPs for raw material testing, sampling and ensuring alignment with regulatory requirements
• Participate in qualification and validation activities for new raw materials, including method development and optimization
• Collaborate with the Supply Chain, Warehouse and Quality Assurance Department to manage the receipt, inspection, and release of raw materials
• Coordinate with third-party laboratories (CTL’s) for outsourced raw material testing and ensure timely reporting of results
• Maintain detailed records of raw material testing and work closely with the QC and MFG departments to support timely material release
• Investigate and resolve Out of Specification (OOS) results and deviations related to raw materials
• Train and mentor other QC staff on raw material testing procedures as required
• Support continuous improvement initiatives to streamline raw material testing processes and ensure compliance with regulatory guidelines
• Collaborate with other departments / CTL’s to troubleshoot and resolve issues related to raw materials or testing procedures
• Maintain required training and training records and provide training to qualify other associates
• Participate in internal assessments and audits as required
• Supply Quality Control data necessary for regulatory submissions
• Support Quality Systems such as; change control, deviation, CAPA, audits, quality metrics, etc.
• Perform other duties as assigned

Preferred Qualifications

• 5+ years focusing on raw material testing in a pharmaceutical or biotech environment is preferred