Quality Compliance Specialist II

About the role

AbbVie is hiring a Quality Compliance Specialist II in Singapore. The specialist supports the execution of site quality compliance programs so that the site adheres to AbbVie policies and current Good Manufacturing Practice (cGMP) requirements under regulatory standards. The role covers internal audits, external inspections, regulatory submissions, product complaints, recalls, quality manuals, quality metrics, quality risk management, data governance and quality plans.

Key responsibilities

• Support inspection management to ensure site readiness for pre-approval and GMP surveillance inspections, and act as co-auditor with the internal lead auditor on self-inspections
• Support the Compliance Partner Program in assigned site departments to meet pharmaceutical and biopharmaceutical manufacturing regulations
• Support product complaints, recall management, the quality manual and site master file, management review, quality metrics, quality risk management, data governance and quality plan management
• Collaborate with site departments to maintain inspection readiness in operations
• Assist with regulatory submissions for product filings and the maintenance of HSA manufacturing licenses and GMP certifications
• Maintain the site master file and quality manual
• Support promotion and training of data integrity, including data integrity risk assessment and audit trail review
• Support data collection and tracking of quality risk management, product complaint and recall, and quality plan activities, including mock recall exercises

Required profile

• Bachelor's or Master's degree in a science (biologicals, biomedical, chemistry, life sciences, pharmaceutical), pharmacy or engineering, or equivalent
• Minimum 2-5 years in a cGMP-regulated environment
• Minimum 2 years of relevant compliance and audit experience preferred
• Specialization in quality/compliance areas such as audit management, product review, customer complaints, management review, quality metrics, quality risk management and data governance in small molecule API or biologics manufacturing preferred

Required skills

• Good knowledge of regulatory standards and guidelines (ICH, CFR, Eudralex, PIC/S) preferred
• Strong verbal and written communication skills
• Problem-solving skills and strong interpersonal skills preferred