QA Lead

Job title: QA Lead

About the Role

The QA Lead will own the end-to-end quality governance for batch release, materials, supplier oversight, and regulatory readiness to ensure compliant manufacturing and timely product disposition. The role emphasizes aseptic filling operations, APQR, audits, regulatory reporting, and continuous improvement across QA operations.

What You'll Do

• Lead batch record review and release decisions for BPR/BCR to ensure completeness, accuracy and cGMP compliance; issue Certificates of Analysis for final disposition.
• Oversee aseptic batch release, sterility assurance, and environmental monitoring data to support release.
• Manage materials quality oversight, including sampling, testing, and on-time release; perform risk assessments and implement mitigations.
• Lead supplier lifecycle management and qualification based on risk criteria and regulatory requirements.
• Govern external service providers and third-party labs; establish and maintain Quality Agreements.
• Prepare APQR end-to-end, coordinating data synthesis, and performing statistical analysis to identify trends.
• Assess CAPA effectiveness and prior-year recommendations; ensure continuous improvement and regulatory readiness.
• Support regulatory reporting and timely archival of APQR; represent QA during audits/inspections.
• Collaborate on tech transfer and cross-functional activities for new product manufacturing; manage project timelines.
• Support QA compliance programs and explore new technologies to improve efficiency.
• Perform other duties as assigned.

What We're Looking For

• Degree in pharmaceutical sciences, life sciences, biology, biotechnology, chemistry, chemical engineering, or related discipline.
• A minimum of 7 years' experience in pharmaceutical/biotechnology quality assurance, GMP compliance, operations or validation, ideally in a multinational company.
• Aseptic filling experience required; experience with a new drug product facility project is expected.
• Knowledge of FDA/EU cGMP and ICH guidelines; exposure to international regulatory networks.
• Strong problem-solving, decision-making, and communication abilities with diverse stakeholders.
• Experience with new facility startup readiness and operation ramp-up.
• Fluent English and ability to interact effectively with team members and stakeholders.

Nice to Have

• Auditor training or certification is advantageous.