Senior QA Specialist – Supplier Audits

• Plan, execute, and lead supplier audits (on-site and remote) in accordance with cGMP, ISO standards, and internal procedures
• Evaluate supplier quality systems, processes, corrective actions, and risk controls to ensure compliance and robust supply continuity
• Prepare comprehensive audit reports, findings, and recommendations, and drive closure of audit observations with stakeholders
• Support supplier qualification activities, including documentation review, risk assessments, and technical evaluations
• Collaborate with Quality, Procurement, Regulatory, and Manufacturing teams to escalate supplier risks and implement mitigation strategies
• Maintain audit schedules, quality intelligence, and supplier performance metrics to support continuous improvement
• Serve as a subject matter expert on supplier quality expectations, training internal partners as needed

• Bachelor’s degree in Life Sciences, Engineering, Chemistry, or related discipline
• Significant experience in supplier quality, audits, and quality systems within a pharmaceutical, biopharmaceutical, or CDMO environment
• Strong knowledge of cGMP, ICH, regulatory expectations, and quality risk management principles
• Demonstrated ability to lead supplier audits and effectively communicate findings to technical and operational stakeholders
• Excellent analytical, report writing, and interpersonal skills with a proactive, solutions-oriented mindset
• Ability to travel as required to support supplier audit activities (domestic and, occasionally, international)

Advanced degree or quality certification (e.g., ASQ CQA)