Quality Compliance Specialist II: Audit & Regulatory

AbbVie; Singapore; On-site; SGD 70,000 - 110,000; Full time

Job summary

AbbVie Singapore is seeking a Quality Compliance Specialist to support site quality programs ensuring cGMP compliance and regulatory alignment. You will assist audits, inspections, and regulatory submissions while promoting data integrity and quality governance across the site.

Ideal candidates bring 2–5 years in a cGMP regulated environment, strong communication skills, and experience in quality/compliance areas such as audits, product reviews, and metrics.

Qualifications

• Minimum 2–5 years in a cGMP regulated environment.
• At least 2 years of compliance and audit experience preferred.
• Specialization in audit management, product reviews, customer complaints, management review, quality metrics and data governance preferred.
• Strong knowledge of regulatory standards (ICH, CFR, Eudralex, PIC/S) preferred.

Responsibilities

• Assist in internal audits and support inspection readiness for regulatory inspections.
• Support Compliance Partner Program in site departments to ensure regulatory compliance.
• Contribute to Quality Plan, Quality Metrics and Quality Risk Management activities.
• Assist in regulatory submissions and maintenance of licenses and GMP certification.
• Support data governance, data integrity assessments and audit trail reviews.
• Assist mock recalls and annual exercises and coordinate related planning.

Skills

Audit management

Regulatory compliance

Quality systems

Data governance

Communication

Problem solving

Adaptability

Education

Bachelor's/Master's in Sciences/Pharmacy/Engineering

Job description

AbbVie Singapore is seeking a Quality Compliance Specialist to support site quality programs ensuring cGMP compliance and regulatory alignment. You will assist audits, inspections, and regulatory submissions while promoting data integrity and quality governance across the site.

Ideal candidates bring 2–5 years in a cGMP regulated environment, strong communication skills, and experience in quality/compliance areas such as audits, product reviews, and metrics.