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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Join AbbVie's Quality Assurance team as an MQA Lead at our Biologics facility in Ballytivnan, Sligo. You will play a key role in ensuring that our marketed and investigational drug products meet global standards, providing quality oversight and guidance for aseptic manufacturing operations in a highly regulated environment.

Responsibilities

• Ensure all products meet requirements for patients, regulatory authorities, and the company.
• Provide quality and compliance oversight to operations, supporting aseptic production and intervention observation.
• Lead investigations into product or manufacturing process non-compliance issues.
• Guide, train, and support shift team members in decision-making.
• Review and audit batch records, manufacturing logs, and operational SOPs.
• Perform line clearance, raw material checks, and maintain product status as required.
• Lead GEMBAs of manufacturing areas and drive continuous improvement.
• Act as SME for quality issues during shift operations.
• Uphold all cGMP, HPRA/FDA, and EHS standards.

• Third-level degree in science, quality, or engineering.
• Minimum 3 years' experience in quality/operations in a GMP-regulated environment (biologics preferred).
• Experience in aseptic processing highly desirable.
• Excellent written/verbal communication and interpersonal skills.
• Demonstrated experience in regulatory inspections
• Proven knowledge of regulatory requirements and strong problem-solving, communication, and interpersonal skills.
• Previous experience as a trainer
• Commitment to quality, attention to detail, and Right First Time ethos
• Previous leadership experience

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. 

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html