Join Abb Vie'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

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

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

Abb Vie'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 Abb Vie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.