Quality Operations Expert II

About the role

The Quality Operations Expert II provides Quality Assurance oversight for final drug substance disposition, batch release, deviation management, change control and Product Quality Review activities. Working closely with Manufacturing, Quality, Regulatory and other site functions, the role ensures products meet GMP standards and regulatory requirements.

Key responsibilities

• Perform final drug substance disposition and release to secondary customers, reviewing all batch‑related quality information.
• Investigate and resolve deviations impacting batch release, acting as the QA reviewer for site deviations.
• Lead root‑cause analyses for quality incidents and coordinate corrective and preventive actions.
• Review, assess and approve change controls, ensuring potential quality and regulatory impacts are evaluated.
• Conduct Product Quality Reviews in line with site and regulatory requirements.
• Identify and implement continuous‑improvement initiatives to strengthen investigation processes and overall effectiveness.
• Participate in internal and external audits and regulatory inspections, providing documentation and subject‑matter support.

Required profile

• Experience in pharmaceutical quality assurance or related GMP environment.
• Strong analytical skills with the ability to lead investigations and assess product impact.
• Effective collaboration with manufacturing, regulatory and cross‑functional teams.
• Attention to detail and commitment to regulatory compliance.

Required skills

• Good Manufacturing Practices (GMP)
• Batch release procedures
• Deviation investigation
• Change control management
• Product Quality Review (PQR) execution