About the role

AI summarised

Operational Quality Senior Manager at a global biopharma company, responsible for ensuring quality compliance in manufacturing and quality operations, overseeing batch documentation, product release, and the QP team. The role leads quality oversight of production activities, drives continuous improvement, and ensures inspection readiness at the Singapore site.

BiopharmaFull-time{'name': 'Quality'}

Key Responsibilities

Accountable for ensuring that products released have been manufactured and released according to the regulatory dossier and cGMP standards.
Ensure compliant review of batch records, lab results, and release documentation.
Oversee investigations for deviations, lab events, complaints, returned goods and product failures; assess impact and ensure corrective and preventative actions, CAPA effectiveness.
Provide shift-based Quality oversight of facilities, equipment and operations to assure real-time cGMP compliance, ALCOA+ data integrity, and timely escalation.
Ensure that quality-related systems, policies and procedures across the site are relevant and compliant to both regulatory and GSK requirements.
Support inspections and sustain acceptable audit status; drive CAPA development and monitor closure.
Manage, develop and train staff; drive quality performance metrics (including RFT) and batch documentation lead time.

Requirements

Bachelor's degree in life sciences, pharmacy, engineering or a related technical field.
Minimum 7 years' experience in pharmaceutical, biopharma or related regulated manufacturing in quality or operations roles.
Practical experience with quality management systems and Good Manufacturing Practice (GMP) requirements.
Demonstrated experience managing deviations, CAPA, change control and investigations.
Strong written and verbal communication skills in English and ability to present clear, objective findings.
This role is on-site in Singapore with regular presence at the manufacturing site.
Advanced degree in a relevant scientific or technical discipline (preferred).
Auditor accreditation or progression through a recognized auditor development programme (preferred).
Experience supporting regulatory inspections and responding to regulatory findings (preferred).
Experience with supplier or third-party quality management and quality agreements (preferred).
Knowledge of risk management, continuous improvement and project management methods (preferred).
Familiarity with digital quality systems and data analytics for quality metrics (preferred).