QA Operations Manager - Sterile Biologics & NPI Transfers

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 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.