Description

This role serves as a senior Quality Assurance subject matter expert responsible for final review and approval of analytical and batch records, oversight of SAP quality transactions, and leadership of OOS, deviations, investigations, and CAPA activities in compliance with cGMP requirements. Key responsibilities include leading supplier and internal audits, supporting regulatory inspections and customer interactions, approving analytical and method development documentation, and ensuring data integrity and material release decisions. The position also provides mentorship to QA staff, supports critical quality decisions, and drives continuous improvement to maintain inspection readiness and regulatory compliance.

• Serve as a subject matter expert for In-Process and Finished Goods Analytical Records (AR) and Batch Records (BR) review and final approval.
• Provide advanced oversight and approval of SAP quality transactions, including material determination and disposition decisions.
• Lead and approve Out of Specification (OOS), Deviations, and Investigations utilizing TrackWise, ensuring root cause analysis and CAPA effectiveness.
• Issue, review, and approve inspection, repackaging, and rework records with minimal oversight.
• Plan, lead, and report Critical Supplier and Quality Service Provider (QSP) audits, including follow-up on corrective actions.
• Review and approve Raw Material Analytical Records and oversee material release decisions.
• Oversee Laboratory and Operations notebook issuance, ensuring compliance with data integrity and cGMP requirements.
• Act as a primary QA contact for customers, internal stakeholders, and regulatory inspections.
• Review and approve Method Validation, Analytical Development, and Method Development reports, providing compliance and technical guidance.
• Design, implement, and maintain cGMP training programs, including training materials, assessments, and effectiveness monitoring.
• Lead or co-lead internal cGMP audits, including risk assessments, audit planning, execution, reporting, and CAPA tracking.
• Provide mentorship, guidance, and technical support to QA Auditors and Inspectors.
• Serve as a senior after-hours QA resource on a rotational basis for critical quality decisions.
• Act as backup or escalation support for Raw Material inspections, sampling activities, and WFI water sampling when required.
• Support continuous improvement initiatives related to quality systems, audit readiness, and regulatory compliance.

All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures.  All employees are expected to report to work regularly and promptly.  Other duties relating to departmental mission, not specifically detailed in this section may be assigned.

• Bachelor's degree in Chemistry or a related scientific discipline, or equivalent industry experience. Advanced coursework in Chemistry, Mathematics, or computer systems is beneficial.
• 58+ years of progressive Quality Assurance experience in a regulated manufacturing environment, preferably pharmaceutical or CDMO.

PI280897772