Abb Vie Biologics Ballytivnan seeks a Senior Manufacturing Compliance Specialist to strengthen our Quality Assurance operations. In this role, you'll help ensure product excellence through quality compliance, incident resolution, and floor-level support within a collaborative manufacturing environment.

Responsibilities

• Ensure all products and process simulations meet standards for market/investigational use.

• Provide quality guidance and compliance oversight throughout manufacturing.

• Lead or support investigations related to non-compliance in product or processes.

• Mentor, train, and provide support to shift team members.

• Audit batch documentation, review logs, and process SOPs.

• Support and execute line clearance, raw material checks, and stability program activities.

• Manage and maintain finished product status, labeling, and quality logs.

• Conduct daily manufacturing area walkarounds and seek process improvements.

• Support quality aspects of MVI, AQL, and NPI process/material handovers.

• Maintain compliance with cGMP, HPRA/FDA, EHS, and Abb Vie standards.

• Third-level degree in science, quality, or engineering.

• Minimum 3 years’ experience in a GMP quality/operations setting (biologics preferred).

• Strong experience in aseptic processing and advanced knowledge of regulatory requirements.

• Excellent written/verbal communication and interpersonal skills.

• Experience as a trainer preferred.

• Demonstrated commitment to quality, problem-solving, and continuous improvement.

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.

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

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.