Sterile QA Operations Lead: GMP & Compliance

HERO Recruitment Ltd.; Sligo; On-site; EUR 80,000 - 100,000; Full time

Job summary

HERO Recruitment Ltd. is assisting in recruiting a QA Operations Manager for Co Sligo. The role focuses on ensuring sterile products are manufactured, filled, and released in compliance with GMP and regulatory requirements to guarantee patient safety and efficacy.

Reporting to the QA Director, you will oversee NPIs and commercial production transfers, manage site QPs and MQA, and coordinate regulatory interactions with authorities as needed.

Qualifications

• Degree in science with manufacturing/pharma experience.
• MSc in Industrial Pharmaceutical Science or similar.
• QP status per Article 49 is required or advantageous.
• Previous supervisory/managerial experience in pharma/biotech manufacturing.

Responsibilities

• Ensure NPIs and Commercial products comply with GMP and regulatory requirements.
• Oversee QA/MQA and product release for NPIs and commercial batches.
• Manage site QPs and regulatory support; liaise with regulators as needed.
• Verify aseptic and sterile manufacturing processes meet end-user and regulatory standards.
• Lead audit activities and regulatory interactions with authorities.

Skills

Leadership

Regulatory compliance

Auditing

GMP knowledge

Manufacturing knowledge

Education

Degree in science

MSc in Industrial Pharmaceutical Science

QP status (Directive 2001/83/EC Article 49)

Job description

HERO Recruitment Ltd. is assisting in recruiting a QA Operations Manager for Co Sligo. The role focuses on ensuring sterile products are manufactured, filled, and released in compliance with GMP and regulatory requirements to guarantee patient safety and efficacy.

Reporting to the QA Director, you will oversee NPIs and commercial production transfers, manage site QPs and MQA, and coordinate regulatory interactions with authorities as needed.