Company Description

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.

Job Description

We are currently hiring a Senior Manager, Bio-Tox Analytical QA, to join our team for a 23-month contract. The Senior Manager, Bio-Tox Analytical QA is responsible for developing and overseeing a robust Quality Assurance strategy focused on the transfer of New Product Introduction (NPI) QC methods to manufacturing sites and Third-Party Laboratories. This role supports the Test Method Gate Review process, reference standard and critical reagent controls, and ensures the quality perspective is built into product development early. Covering mAbs, ADCs, Neurotoxins, Gene Therapy, and emerging biological entities across Immunology, Oncology, Neuroscience, Eyecare, and Aesthetics, this position acts as a quality technical lead supporting strategic research, compliance, and collaboration across multidisciplinary teams.

Responsibilities:

• Review and approve Drug Substance and Drug Product specifications for Biologics, Neurotoxins, and Gene Therapy products.
• Support QA/QC business units by delivering program strategies, managing projects, and overseeing unit operations in line with business objectives.
• Provide quality technical leadership in multidisciplinary settings to keep activities on track with timelines and business needs.
• Support and execute development, manufacturing, and customer-centric plans.
• Develop, negotiate, and finalise project timelines and cost estimates to fulfil business and customer requirements.
• Apply advanced scientific expertise to manage and support complex, multi-disciplinary projects.
• Use advanced technical writing skills to develop protocols and reports for product registration and business needs.
• Oversee processes and procedures to ensure product quality and regulatory compliance.
• Establish and enforce quality system procedures, interfacing across development, operations, quality, compliance, and regulatory functions.

Qualifications

• Bachelor’s degree in Chemistry, Pharmacy, Biology, or a related scientific/technical field (required).
• Minimum 5 years’ experience in quality assurance, operations, regulatory or relevant area, with at least 2 years in management.
• Familiarity with product/process requirements, customer regulations (internal and external), and QA systems and GxP compliance for device, biologics, and pharmaceutical products.
• Strong influencing, motivational, and relationship-building skills across all staff levels.
• Effective at making operational/business decisions independently.
• Excellent written and oral communication skills and proficiency in English.
• Strategic thinker with enterprise-wide vision for compliance and business needs.
• Strong negotiation and collaboration skills with the ability to anticipate needs and manage matrix teams.
• Advanced computer skills, particularly in enterprise systems such as SolTraqs, Attache, and Attache Pro.

This role can be performed from one of our sites in Ireland or near one of our sites.

The internal grade may vary depending on international location.

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.

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