QA Operations Manager – Sterile Drug Manufacturing

Sigmar Recruitment; Sligo; On-site; EUR 85,000 - 115,000; Full time

Job summary

Sigmar Recruitment is seeking a QA Operations Manager to oversee sterile product manufacturing, filling and release at our client's site in Ireland, ensuring compliance with GMP, regulatory requirements and patient safety.

Reporting to the QA Director, you will manage QPs and MQAs, drive NPIs to commercial transfer, and maintain up-to-date knowledge of EU GMP Annex 1, FDA/EMA expectations and audit readiness. This role requires strong leadership and regulatory collaboration.

Qualifications

• Degree in a science discipline with pharma industry experience.
• MSc in Industrial Pharmaceutical Science or regulatory-compliant MSc for QP status.
• Experience in FDA and EMA approved pharmaceutical environments.
• Supervisory/managerial experience in manufacturing in biotech/pharma/medical devices.
• Experience in aseptic filling, drug product inspection, solutions prep and sterilization.
• Proven track record in audit management and regulatory interactions.

Responsibilities

• Oversee NPI and commercial product manufacturing, ensuring GMP compliance.
• Own transfer of NPIs to commercial manufacturing with documented approvals.
• Manage site QPs and MQAs, including batch release and regulatory support.
• Ensure sterile/aseptic products meet end-user and regulatory requirements.
• Coordinate with QA Director and Quality Systems to achieve goals.

Skills

GMP experience

QA management

Regulatory audits

Supervisory experience

Aseptic filling

FDA/EMA familiarity

Quality systems

Education

Science degree

MSc in Industrial Pharmaceutical Science

Job description

Sigmar Recruitment is seeking a QA Operations Manager to oversee sterile product manufacturing, filling and release at our client's site in Ireland, ensuring compliance with GMP, regulatory requirements and patient safety.

Reporting to the QA Director, you will manage QPs and MQAs, drive NPIs to commercial transfer, and maintain up-to-date knowledge of EU GMP Annex 1, FDA/EMA expectations and audit readiness. This role requires strong leadership and regulatory collaboration.