Quality Assurance Compliance Manager

AbbVie; Dublin; On-site; EUR 90,000 - 120,000; Full time

Job summary

AbbVie North Dublin is seeking a Quality Assurance Compliance Manager to lead the development and maintenance of the quality system, ensuring GMP compliance and readiness for regulatory inspections. You will guide a team of quality professionals and act as a SME for site quality systems.

The role includes oversight of CAPA, Change Management, training, supplier management, and continued improvement initiatives, including adoption of AI-enabled tools.

Qualifications

• Third-level qualification in a science discipline.
• At least 8 years in healthcare or pharmaceutical industry.
• Two+ years people management experience.
• Demonstrated audit and inspection management experience.
• Excellent understanding of cGMP and manufacturing operations.

Responsibilities

• Lead the QA aspects of the site quality system including CAPA, Change Management, Document Management, Complaints, Training, Inspection Readiness, and Management reviews.
• Develop and manage the quality system to ensure compliance with US FDA, ICH, EudraLex and AbbVie requirements.
• Prepare and maintain the Site Master File, Quality Manual and Quality Plans.
• Lead regulatory inspection and corporate audit preparation for the assigned area and report quality performance to site leadership.
• Champion AI-enabled tools to drive process optimisation and continuous improvement.

Skills

Leadership

Quality mindset

Problem-solving

Communication

Attention to detail

Education

Science degree

Tools

Veeva Vault

TrackWise

ComplianceWire

Microsoft Office

Job 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.

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 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

We are seeking a Quality Assurance Compliance Manager to lead the development and maintenance of the quality system at AbbVie North Dublin. The role will ensure compliance with applicable regulatory requirements and help ensure that products manufactured at the site meet Good Manufacturing Practice (GMP), customer, regulatory authority and AbbVie requirements.

This is a leadership role with responsibility for the site compliance programme, quality systems performance and the development of a team of quality professionals. The successful candidate will provide technical leadership, support inspection readiness and act as a key quality systems subject matter expert for the site.

Responsibilities

• Lead the Quality Assurance aspects of the site quality system, including Management Review, Corrective and Preventive Action (CAPA), Change Management, Document Management, Complaints, Training, Inspection Readiness and Management, the Self-Inspection Programme, Supplier Management, and Quality and Technical Agreements.
• Develop and manage the quality system to ensure compliance across all departments and personnel with US FDA, ICH, EudraLex and AbbVie requirements and standards.
• Prepare and maintain the Site Master File, Quality Manual and Quality Plans.
• Ensure that products manufactured at AbbVie meet the requirements of customers, regulatory authorities and the company.
• Develop and maintain quality system performance measures and report results through management review and quality performance meetings.
• Liaise with AbbVie quality and compliance colleagues, the FDA, the Health Products Regulatory Authority (HPRA) and other regulatory bodies.
• Lead regulatory inspection and corporate audit preparation for the assigned area, present technical data to stakeholders and ensure significant quality events are escalated to site quality leadership.
• Identify and lead continuous improvement and simplification initiatives, including the delivery of new quality systems initiatives.
• Champion and support the adoption of AI-enabled tools to drive process optimisation, simplification, and continuous improvement initiatives.
• Provide technical leadership and quality systems guidance to functional areas, collaborating with key stakeholders to support site goals and objectives.
• Lead, manage and develop quality professionals and direct reports within the QA Compliance group, including goal setting, performance reviews, development plans and talent management.
• Prioritise team activities in line with business needs, support timely closure of quality issues and promote a Right First Time approach.
• Act as delegate for the Associate Director, QA Compliance, as required.
• Adhere to and support all Environment, Health and Safety standards, procedures and policies.

Qualifications

• A third-level qualification in a science discipline and at least 8 years' experience in the healthcare or pharmaceutical industry.
• A minimum of two years of people management experience.
• Demonstrated audit and inspection management experience.
• Excellent understanding of current Good Manufacturing Practice (cGMP) and manufacturing operations.
• Qualified Person (QP) eligibility is desirable.

Knowledge, skills and behaviours

• Deep knowledge of GMP requirements and regulations, with the expertise to assess day-to-day quality issues and make sound quality decisions while maintaining patient focus and safeguarding company reputation.
• Strong problem-solving, analytical and decision-making skills, with the ability to propose and implement effective solutions.
• High attention to detail, accuracy and compliance, combined with the ability to manage priorities in line with business demands.
• Results-focused approach, with integrity, personal accountability, initiative and the tenacity to bring issues to closure.
• Strong verbal and written communication, interpersonal, influencing and leadership skills.
• Proficiency in Microsoft Office. Experience with Veeva Vault, TrackWise and ComplianceWire is desirable.

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