Sterile Pharma QA Operations Manager

Sigmar Recruitment; Sligo; On-site; EUR 90,000 - 110,000; Full time

Job summary

Sigmar Recruitment is seeking a QA Operations Manager in Ireland to ensure sterile products meet regulatory and quality standards. You will oversee NPIs and commercial transfers, manage site QPs and MQA, and ensure batches comply with marketing authorisations.

The role requires MSc in Industrial Pharmaceutical Science with QP status per Directive 2001/83/EC, and substantial experience in FDA/EMA environments, audit management, and supervisory manufacturing roles.

Qualifications

• Degree in science with experience in healthcare/pharmaceutical industry.
• MSc enabling QP status per Directive 2001/83/EC Article 49.
• Experience in FDA/EMA approved pharmaceutical environments.
• Supervisory/managerial experience in manufacturing (biotech/pharma/medical device).
• Experience in aseptic filling, visual inspection, and sterilization operations.

Responsibilities

• Ensure NPI and Commercial products meet GMP requirements.
• Own and oversee NPIs transfer to commercial manufacturing processes.
• Manage site QPs and Manufacturing Quality Assurance (MQA), including batch release.
• Ensure sterile/aseptic products meet end-user, regulatory, and company requirements.
• Verify batches manufactured comply with the marketing authorisation provisions.
• Ensure manufacturing adheres to GMP (EU Annex 1, FDA regulations).
• Validate principal manufacturing/testing processes and production conditions.
• Authorize exceptions/changes to production or quality control with defined system.
• Keep knowledge up to date with progress in quality management and regulatory changes.
• Ensure effective NPIs transfer to site and progression to clinical/commercial manufacturing.
• Collaborate with QA Director, QC, and Quality Systems to meet customer, quality, regulatory, and financial goals.

Skills

QA management

GMP compliance

Regulatory interaction

Audit management

Leadership

Education

Bachelor's degree in science

MSc in Industrial Pharmaceutical Science

Job description

Sigmar Recruitment is seeking a QA Operations Manager in Ireland to ensure sterile products meet regulatory and quality standards. You will oversee NPIs and commercial transfers, manage site QPs and MQA, and ensure batches comply with marketing authorisations.

The role requires MSc in Industrial Pharmaceutical Science with QP status per Directive 2001/83/EC, and substantial experience in FDA/EMA environments, audit management, and supervisory manufacturing roles.