QA Operations Manager

AbbVie; Sligo; On-site; EUR 90,000 - 130,000; Full time

Job summary

AbbVie is seeking a QA Operations Manager for its Ballytivnan facility in Ballytivnan, Sligo. The role ensures sterile products are manufactured, filled, and released in compliance with GMP and regulatory requirements.

You will lead site QA activities, supervise QPs and MQAs, and coordinate with global QA and regulatory groups to support NPIs and commercial manufacturing. Strong regulatory and audit experience is essential.

Qualifications

• Senior-level QA operations experience in pharma/biotech manufacturing.
• Licensed/qualified person status per Article 49 where applicable.
• Experience with aseptic filling, sterilization, and GMP compliance.

Responsibilities

• Oversee GMP-compliant manufacturing, filling and release of sterile products (NPI and Commercial).
• Manage site QPs and MQAs, including batch release and regulatory support.
• Coordinate transfer of NPIs to clinical/ commercial manufacturing.
• Liaise with regulatory bodies (FDA, EMA, HPRA) and AbbVie QA/regulatory groups.
• Ensure manufacturing adheres to EU GMP Annex 1 and applicable regulations.
• Maintain up-to-date quality knowledge and oversee process validation.

Skills

QA leadership

Regulatory liaison

Audit management

Problem solving

Education

MSc Industrial Pharmaceutical Science

QP status per Directive 2001/83/EC

Degree in science

Tools

QA systems

Regulatory guidelines

Job description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience, and products and services in our Allergan Aesthetics portfolio.

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 AbbVie Biologics Ballytivnan (ABB) to meet regulatory requirements for patient safety and efficacy and comply with Regulatory Authority Requirements.

Responsibilities

• Ensure that all NPI and Commercial Products manufactured at AbbVie Biologics 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 AbbVie Biologics.
• 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 ABB 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.
• Liaise with AbbVie global Quality Assurance and Regulatory groups, FDA, HPRA and other Regulatory bodies (where applicable).
• Liaise with AbbVie Product Quality, S&T and Regulatory affairs function in relation to product filing support.
• 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.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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