Quality Compliance Specialist II — Audit & Regulatory Readiness

AbbVie Inc.

Singapore

On-site

SGD 70,000 - 110,000

Full time

9 days ago

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Job summary

AbbVie Inc. is seeking a Quality Compliance Specialist to support site quality programs and regulatory adherence across manufacturing operations. You will assist in internal audits, inspection readiness, and management of the Quality Manual and related systems.

The role emphasizes data governance, quality metrics, risk management, and collaboration with cross-functional teams to maintain cGMP compliance in a fast-paced biopharma environment.

Qualifications

  • 2–5 years in a cGMP environment is required.
  • Experience in compliance and audit is preferred.
  • Knowledge of regulatory guidelines (ICH, CFR, Eudralex, PIC/S) is preferred.

Responsibilities

  • Support site quality compliance programs and regulatory standards.
  • Assist internal audits and external inspection readiness activities.
  • Help manage Quality Manual, Site Master File, and Quality Plan.
  • Support data governance, quality metrics, and risk management.

Skills

cGMP compliance
Audit management
Regulatory standards (ICH CFR)
Problem solving
Communication skills
Interpersonal skills

Education

Bachelor's/Master's in Sciences or related

Job description

AbbVie Inc. is seeking a Quality Compliance Specialist to support site quality programs and regulatory adherence across manufacturing operations. You will assist in internal audits, inspection readiness, and management of the Quality Manual and related systems.

The role emphasizes data governance, quality metrics, risk management, and collaboration with cross-functional teams to maintain cGMP compliance in a fast-paced biopharma environment.

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