Senior Quality Operations Lead - GxP/24x7

Allergan; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

AbbVie Operations Singapore seeks an experienced Quality Operations leader to supervise a team ensuring cGMP compliance across QA, manufacturing, and related functions. You will drive batch release, investigations, and change control while coordinating with global Quality Centers of Excellence.

The role requires 8+ years in GxP environments and 2+ years of people management, with strong written and verbal communication skills to interface with auditors and internal stakeholders.

Qualifications

• 8+ years of experience in a GxP environment and Quality Operations.
• 2+ years of people management experience.
• Strong knowledge of quality/compliance management for APIs/Biologics.
• Ability to quickly understand products and processes to assess quality issues.
• High integrity and strong work ethic; commitment to quality.
• Solid knowledge of GxP requirements and regulations.
• Excellent verbal and written communication skills.

Responsibilities

• Supervise routine activities (batch review, release, walkthrough, tag-out) independently.
• Lead training for batch release and MES review; guide colleagues across disciplines and front auditors.
• Identify and resolve technical/operational problems; collaborate with peers and cross-site teams to resolve issues.
• Lead or support cross-functional projects; present updates to management.
• Review and approve SOPs; ensure compliance with local procedures.
• Support investigations of non-conformances; perform root cause analysis and CAPA.
• Manage change plans and PQR reports; ensure lifecycle completion per CP framework.
• Mentor direct reports and develop team capabilities.
• Oversee batch record reviews for API/BDS; ensure timely disposition and QA release.
• Lead New Product Introductions (Quality) and product changeover activities.

Skills

GxP knowledge

People management

Quality compliance

Decision making

Communication skills

Education

Bachelor's degree in Sciences/Pharmacy/Engineering

Job description

AbbVie Operations Singapore seeks an experienced Quality Operations leader to supervise a team ensuring cGMP compliance across QA, manufacturing, and related functions. You will drive batch release, investigations, and change control while coordinating with global Quality Centers of Excellence.

The role requires 8+ years in GxP environments and 2+ years of people management, with strong written and verbal communication skills to interface with auditors and internal stakeholders.