QA Compliance Specialist (Part Time)

AbbVie Inc.; Sligo; Hybrid; EUR 45,000 - 65,000; Full time

Job summary

AbbVie Inc. is seeking a Quality Compliance Specialist to support and maintain the site's Quality Management System in Ireland, ensuring adherence to cGMP and regulatory guidelines.

You will lead PQR activities, manage change controls, CAPA, and supplier quality, collaborating with Manufacturing, Quality Control, and Regulatory bodies. Ideal candidates have at least 2 years in GMP QA roles, a science/quality/engineering degree, and strong analytical, communication, and problem-solving skills to

Qualifications

• Bachelor-level degree in Science, Quality, Engineering, or related discipline.
• Minimum 2 years' experience in QA/Quality Compliance within a GMP environment.
• Strong knowledge of cGMP and pharmaceutical regulatory expectations.

Responsibilities

• Coordinate and maintain the site Quality Management System to ensure compliance with AbbVie policies and regulatory requirements.
• Lead and support Product Quality Review (PQR) activities.
• Manage technical agreements, including initiation, review, approval, implementation, and document control.
• Coordinate quality metrics, track-and-trend activities, and performance reporting to support Manufacturing and Quality Control operations.
• Drive the application of Quality Risk Management principles across site activities, including Risk Control Strategies and FMEA processes.
• Support investigations of customer complaints, deviations, and non-conformances with CAPA implementation and verification.
• Provide quality oversight and approval for validation activities (systems, processes, equipment).
• Support New Product Introduction (NPI) projects and collaborate with Manufacturing, Technical Operations, and Laboratory functions.
• Monitor quality system performance and present metrics during management review and site performances.
• Coordinate change control activities and assess quality impact of proposed changes.
• Provide guidance on cGMP, quality system requirements, and regulatory expectations.
• Act as liaison with corporate quality and regulatory agencies (HPRA, FDA, etc.).
• Perform regulatory assessments and policy reviews to ensure ongoing compliance.
• Initiate and manage quality event records, investigations, and CAPA activities.
• Support supplier quality activities including vendor qualification and audits.
• Participate in internal audits and inspections, and readiness activities.

Skills

Quality Assurance

GMP compliance

QMS

Regulatory knowledge

Education

Bachelor's degree in Science/Quality/Engineering or related field

Job description

Company Description

About AbbVie

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

Job Description

The Quality Compliance Specialist is responsible for supporting and maintaining the site's Quality Management System (QMS) to ensure compliance with AbbVie standards, cGMP requirements, and applicable regulatory guidelines. The role plays a key part in ensuring that products manufactured at AbbVie consistently meet the expectations of patients, regulatory authorities, and the company.

Key Responsibilities

• Coordinate and maintain the site Quality Management System, ensuring compliance with AbbVie policies and applicable regulatory requirements.
• Lead and support Product Quality Review (PQR) activities.
• Manage technical agreements, including initiation, review, approval, implementation, and document control.
• Coordinate quality metrics, track-and-trend activities, and performance reporting to support Manufacturing and Quality Control operations.
• Drive the application of Quality Risk Management (QRM) principles across site activities, including Risk Control Strategies (RCS) and FMEA processes.
• Support investigations of customer complaints, deviations, and non-conformances, ensuring robust CAPA implementation and effectiveness verification.
• Provide quality oversight and approval for validation activities, including systems, processes, and equipment.
• Support New Product Introduction (NPI) projects and collaborate closely with Manufacturing, Technical Operations, and Laboratory functions.
• Monitor quality system performance and present key metrics during management review and site performance meetings.
• Coordinate change control activities and assess quality impact associated with proposed changes.
• Provide guidance to site personnel on cGMP, quality system requirements, and regulatory expectations.
• Act as a key liaison with corporate quality functions and regulatory agencies, including HPRA, FDA, and other regulatory authorities.
• Perform regulatory assessments and policy reviews to ensure ongoing compliance.
• Initiate and manage quality event records, investigations, and CAPA activities as required.
• Support supplier quality activities, including vendor qualification, supplier performance monitoring, notifications, and audits.
• Participate in and support internal audits, regulatory inspections, customer audits, and inspection readiness activities, including audit responses and evidence management.
• Contribute to continuous improvement and compliance initiatives across the site.
• Ensure adherence to all Environmental, Health & Safety (EHS) standards, procedures, and policies.

Qualifications

Required

• Third-level qualification in Science, Quality, Engineering, or a related discipline.
• Minimum of 2 years' experience in a Quality Assurance, Quality Compliance, or related GMP environment.
• Strong knowledge of cGMP requirements and pharmaceutical regulatory expectations.
• Experience working within a Quality Management System in a regulated manufacturing environment.

Preferred

• Experience supporting regulatory inspections and audits.
• Knowledge of quality risk management, change control, CAPA, supplier quality, and validation processes.
• Experience within the pharmaceutical, biologics, or medical device industry.

Skills & Competencies

• Strong attention to detail with a commitment to quality and compliance.
• Excellent problem-solving and analytical skills.
• Ability to assess and interpret regulatory requirements and implement effective solutions.
• Strong communication and stakeholder management skills, both written and verbal.
• Proven ability to work independently while collaborating effectively across cross-functional teams.
• Results-driven mindset with a focus on continuous improvement and Right First Time principles.
• High level of integrity, accountability, and professionalism.
• Ability to influence stakeholders and drive compliance-focused outcomes.

Additional Information

Deadlines for applications is the 15th October 2026

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