Manager Quality Operations

The Manager Quality Operations is responsible for overseeing and leading the Quality Operations team, to ensure day-to-day execution of Quality Assurance activities on the manufacturing floor and within the quality system in accordance with Good Manufacturing Practices and regulatory requirements.

Key Responsibilities:

• People management accountability — full line management of the QA Operations team including objective setting, performance reviews, development plans, capacity management, and GMP training oversight.
• Lead a dedicated Quality Operations team responsible for day-to-day quality operations interfaces, within a dynamic dual MAH/CMO pharmaceutical environment. Act as the primary quality decision-maker for operational disruptions while applying risk-based decisions to safeguard product quality and patient safety
• QP & Accountable for batch release and disposition — oversight batch release team, review of batch records, in-process controls, and yield evaluations; holding final approval authority on disposition recommendations prior to QP certification.
• Own Product related investigations related to deviations, OOS/OOT, and complaints management system end-to-end — from incident classification to investigation through CAPA plan design, assignment, closure, and effectiveness verification.
• Lead recall and market withdrawal operations for both MAH-initiated and CMO-received scenarios, including regulatory authority notification, batch traceability, mock recall programs, and QTA compliance.
• Product & Process change control management—oversight   change controls impact assessments and risk management, approving outputs, representing Quality in cross-functional change boards, and engaging Regulatory Affairs where MA impact is identified, monitoring of Change control completion, verification and effectives checks
• Oversee Product Quality Reviews and product risk assessments — ensuring PQRs are developed and critically evaluated in due time and in line with EudraLex Volume 4. Oversee the Quality operation team deliverables in relation to product Lifecyle management Risk Assessments ( eg. elemental impurities, Nitrosamines)
• Minimum 8 years GMP QA experience in pharmaceutical manufacturing, with at least 2 years in a supervisory or team lead role; in-depth knowledge of EudraLex Volume 4, ICH Q8/Q9/Q10 required.
• Cross-functional leadership scope — interfaces with Production, QC, Supply Chain, Regulatory Affairs, Technical, and external CMO partners;  strong teamwork and communication skills is essential / eQMS/eDMS experience is preferred.