Job Description 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.
Qualifications 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 Additional Information 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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