Senior Quality Systems & Compliance Specialist

About the role

The Senior Quality Systems & Compliance Specialist ensures that all quality-related documentation, investigations, and corrective actions are performed safely, on time, and in full compliance with GMP and internal standards. This role partners with functional leads to set performance goals and oversees vendor audit activities.

Key responsibilities

• Review batch records, SOPs, investigations, corrective actions, change controls, and technical documents for compliance.
• Establish group goals and metrics with the Function Lead and manage performance against those targets.
• Ensure safe, high‑quality work execution in a timely and compliant manner.
• Lead or support investigations of non‑conformances and drive corrective/preventive actions.
• Oversee the GMP vendor audit schedule, coordinate auditors and vendors, and manage audit report reviews and closure documentation.
• Submit observation reports to vendors, customers, and regulatory bodies, tracking response timelines.
• Maintain documentation control for master batch records, specifications, and methods.
• Handle investigations, complaints, deviations, CAPAs, and APRs.

Required profile

• Extensive experience in quality systems, GMP compliance, and quality assurance within a regulated environment.
• Proven ability to manage vendor audits, documentation control, and corrective action processes.
• Strong analytical skills to investigate non‑conformances and implement effective solutions.
• Excellent organizational skills to set goals, track metrics, and ensure timely completion of tasks.

Required skills

• GMP compliance
• Quality assurance documentation control
• Audit management
• Investigation and CAPA processes