Associate Director, Quality Assurance Operations

Overview

• Lead quality assurance operations for downstream purification manufacturing activities in a GMP environment.
• Provide on-the-floor oversight, ensuring compliance and operational excellence in drug substance production.
• Collaborate with cross-functional teams to support manufacturing and product release initiatives.
• Drive quality expertise to ensure compliant manufacture of clinical and commercial GMP materials.
• Support operational excellence initiatives and contribute to continuous improvement projects.
• Provide technical guidance during investigations and manage deviation and change control processes.
• Ensure adherence to industry regulations and maintain strong quality judgment in decision-making.
• Work on-site, adhering to safety protocols and fostering a quality-driven environment.

Key Responsibilities & Duties

• Provide quality operations support, overseeing batch record lifecycle processes and approvals.
• Offer technical guidance during investigations for complex manufacturing events and deviations.
• Review and approve site-specific deviations and investigations with a focus on quality compliance.
• Support product release activities, including issuance of Certificates of Conformance.
• Manage CAPA records, functioning as CAPA manager for major or minor corrective actions.
• Serve as QA reviewer for downstream purification change control records and impact assessments.
• Lead preparation activities for Pre-approval Inspections and respond to observations effectively.
• Own quality procedures, ensuring effective deployment of systems and processes.

Job Requirements

• Bachelor’s degree in Biological or Chemical Sciences with 9+ years of relevant experience.
• Master’s degree in Biological or Chemical Sciences with 8+ years of relevant experience preferred.
• Strong expertise in downstream drug substance purification processes and GMP compliance.
• Proficiency in root cause analysis techniques such as 5-why, Kepner-Tregoe, and DMAIC.
• Experience in writing concise investigation summaries and adapting technical reports.
• Knowledge of industry regulations including CFR, USP, EP, and JP standards.
• Demonstrated leadership and management experience in quality assurance operations.
• On-the-floor biologics experience in a GMP environment required.