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

Job Description

Reporting to the QA Director, the QA Operations Manager will ensure that sterile products (New Product Introduction (NPI) and Commercial) are manufactured, filled and released at the site meet the regulatory requirements for patient safety and efficacy and comply with Regulatory Authority Requirements that the product is been released too.

Main duties and responsibilities:

• Ensure that all NPI and Commercial Products manufactured are in accordance with the relevant GMPs.
• Ownership and Accountability for the Management and oversight for effective product transfer of NPIs and transfer to commercial manufacturing processes within the site.
• Management of site QPs and Manufacturing Quality Assurance (MQA), including NPI and Commercial batch release, product performance and regulatory support.
• Ensuring that sterile and aseptic products manufactured at the site meet requirements of end users, Regulatory Authorities and of the company.
• Verify that batches are manufactured and comply with the provisions of the marketing authorisation.
• Ensure manufacture has been carried out in accordance with all applicable Good Manufacturing Practice, e.g., EU GMP Annex 1 and FDA regulations.
• Ensure the principal manufacturing and testing processes have been appropriately validated; account has been taken of the actual production conditions and manufacturing records.
• Confirm that any exceptions or planned changes in production or quality control have been authorised by the persons responsible in accordance with a defined system. Any changes requiring variation to the marketing or manufacturing authorisation have been notified to and authorised by the relevant authority.
• Maintain knowledge and experience is up to date in the light of technical and scientific progress and changes in quality management relevant to the products they are required to certify.
• Ensure effective transfer of NPIs to site and its progress into clinical / commercial manufacturing
• Work with QA Director, Quality Control and Quality Systems group to ensure site meets its customer, quality service, regulatory and financial goals.

Qualifications

• Degree level qualification in a science discipline with previous experience in the healthcare/pharmaceutical industry.
• MSc in Industrial Pharmaceutical Science or similar course recognized by Regulatory Authority to permit Qualified Person (QP) status as per Article 49 of Directive 2001/83/EC
• Industrial experience gained in a FDA and EMA approved pharmaceutical environment.
• Previous supervisory and managerial experience in a manufacturing related area in a Biotechnology, Pharmaceutical or Medical Device organisation
• Experience in manufacturing processes of drug product/substance, including aseptic filling, visual inspection of drug product, solutions preparation, and sterilization operations preferable.
• Proven track record in audit management and regulatory interaction management.