QA Operations Manager – Global Biologics & Medical Devices

Wallace Myers International; Sligo; On-site; EUR 90,000 - 130,000; Full time

Job summary

Wallace Myers International is recruiting a QA Operations Manager for a Global Biologics Fill-Finish & Medical Device facility in Sligo. This is a full-time, permanent role reporting to the QA Director, focused on GMP-compliant manufacturing, release and quality assurance to ensure patient safety.

You'll oversee NPIs and commercial transfers, management of site QPs and MQAs, regulatory interactions with authorities, and ensure aseptic processes meet regulatory requirements while driving

Qualifications

• Degree in a science discipline with pharma/healthcare industry experience.
• MSc in Industrial Pharmaceutical Science or regulatory-authority-recognised equivalent.
• Experience in FDA/EMA pharma environments.
• Previous supervisory/managerial experience in biotech/pharma/medical devices.
• Experience with aseptic filling, inspection and sterilization operations preferable.
• QP licensure ideal but not required.

Responsibilities

• Ensure NPI and Commercial products meet GMP requirements.
• Ownership of product transfer for NPIs to commercial manufacturing processes.
• Manage site QPs and MQAs, batch release and regulatory support.
• Ensure sterile/aseptic products meet end-user and regulatory requirements.
• Audit management and regulatory interactions.
• Liaise with global QA and regulatory groups for product filing support.

Skills

Leadership

Supervisory experience

Regulatory liaison

Audit management

Education

Degree in science

MSc in Industrial Pharmaceutical Science

Job description

Wallace Myers International is recruiting a QA Operations Manager for a Global Biologics Fill-Finish & Medical Device facility in Sligo. This is a full-time, permanent role reporting to the QA Director, focused on GMP-compliant manufacturing, release and quality assurance to ensure patient safety.

You'll oversee NPIs and commercial transfers, management of site QPs and MQAs, regulatory interactions with authorities, and ensure aseptic processes meet regulatory requirements while driving