Senior Manager, GMP Quality

Responsibilities

• Serve as the QA lead for commercial finished product (FP) batch review and disposition activities, ensuring timely and compliant release of commercial product for distribution.
• Perform comprehensive review and approval of executed batch records, deviations, investigations, analytical data, Certificates of Analysis (CoAs), and associated release documentation for commercial product disposition.
• Provide QA oversight for commercial manufacturing, packaging, labeling, testing, storage, and release operations performed at CMOs, contract laboratories, and distribution partners.
• Collaborate cross-functionally with Pharmaceutical Development & Manufacturing (PDM/CMC), Supply Chain, Regulatory Affairs, Technical Operations, Validation, and external partners to ensure uninterrupted commercial product supply.
• Represent QA on cross-functional teams and serve as a resource for quality and compliance questions, issues, and planning across the commercial organization, including providing guidance based on current global regulations, industry standards, and best practices.
• Support QA activities associated with deviation investigations, CAPA plans, change controls, product impact assessments, complaints, recalls, annual product reviews, and other commercial GMP quality systems.
• Ensure compliance with FDA, EMA, ICH, and other applicable global GMP regulations governing commercial manufacturing and product release activities.
• Maintain quality metrics related to batch disposition timelines, deviations, product quality trends, and overall effectiveness of commercial quality systems, and communicate risks and compliance challenges to senior management.
• Lead periodic review and revision of GMP-related SOPs, work instructions, and quality procedures to ensure alignment with evolving regulatory expectations and business needs.
• Support quality review of regulatory submissions and post-approval filings, including NDA supplements, annual reports, and responses to health authority inquiries.

Qualifications

• A Bachelor's degree in a scientific or technical discipline is required.
• A minimum of 8+ years of experience in GMP Quality in the pharmaceutical industry, with experience in late-stage /commercial drug product development.
• Excellent analytical skills and a strong technical background in small molecule process development, and testing are strongly desired.
• Knowledge of applicable US and Global compliance regulations and industry practices.
• Ability to critically evaluate and troubleshoot complex problems with diligence.
• Strong teamwork, collaboration, and management skills.
• Ability to manage multiple priorities and aggressive timelines.
• Highly responsible, self-motivated professional with enthusiasm and passion for the work.
• Highly proficient with various Microsoft and other computerized systems (e.g., Word, Outlook, Excel, PowerPoint, Visio, etc.).