QA Operations Manager

About AbbVie

AbbVie is dedicated to pioneering and delivering innovative therapies that address critical medical conditions today and tackle future health challenges. Their focus spans key therapeutic areas such as immunology, oncology, neuroscience, along with products in their Allergan Aesthetics portfolio.

Role Overview

Reporting directly to the QA Director, the QA Operations Manager will oversee the manufacturing, filling, and release of sterile products at AbbVie Biologics Ballytivnan (ABB). This role ensures compliance with regulatory requirements guaranteeing patient safety and product efficacy for both New Product Introductions (NPIs) and commercial products.

Key Responsibilities

• Guarantee all manufactured NPIs and commercial products comply with the appropriate Good Manufacturing Practices (GMPs).
• Lead the management and oversight for smooth product transfers of NPIs and commercialization within AbbVie Biologics.
• Supervise site Qualified Persons (QPs) and Manufacturing Quality Assurance teams, ensuring batch releases and regulatory adherence.
• Assure that sterile and aseptically manufactured products meet end-user, regulatory, and company standards.
• Verify batch manufacturing aligns with marketing authorisation provisions.
• Confirm manufacturing processes follow applicable GMP standards, including EU GMP Annex 1 and FDA regulations.
• Ensure validation of principal manufacturing and testing procedures, considering actual production conditions and documentation.
• Authorize and manage any production or quality control exceptions or planned changes through established systems and notify relevant authorities for any variations.
• Maintain current knowledge on technical, scientific, and quality management developments applicable to product certification.
• Collaborate with global Quality Assurance, Regulatory teams, FDA, HPRA, and other relevant regulatory bodies.
• Coordinate with Product Quality, Science & Technology, and Regulatory Affairs for product filing support.
• Drive effective transfer of NPIs into clinical and commercial manufacturing phases.
• Work alongside the QA Director, Quality Control, and Quality Systems to meet customer, quality, regulatory, and financial objectives.

Qualifications and Experience

• A degree in a scientific discipline with experience in the healthcare or pharmaceutical sector.
• MSc in Industrial Pharmaceutical Science or an equivalent qualification recognized by regulatory authorities, allowing Qualified Person status (per Article 49 of Directive 2001/83/EC).
• Industrial experience within FDA and EMA-certified pharmaceutical environments.
• Proven leadership and managerial experience in manufacturing within biotechnology, pharmaceuticals, or medical device industries.
• Hands-on knowledge of drug product manufacturing processes, including aseptic filling, visual product inspection, solution preparation, and sterilization methods preferred.
• Strong background in audit management and handling regulatory interactions.

Additional Information

AbbVie values equal opportunities and commits to integrity, innovation, life transformation, and community service. They are an Equal Opportunity Employer welcoming veterans and disabled candidates.