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 (https://twitter.com/abbvieireland) , Facebook, Instagram (https://www.instagram.com/abbvieireland/) , YouTube and LinkedIn.

Job Description

The Associate Director of Quality/ Head of Compliance is responsible for providing strategic and innovative quality management and governance that drives global market compliance and quality excellence across the organisation. The position is a key leadership role in the Commercial and Distribution Quality organisation, that partners and collaborates with global operational stakeholders to align business and quality system strategies, enabling smart data driven decisions that enhance efficiency and improved performance.

Responsibilities:

• Work with AbbVie Quality leadership to develop strategy for optimizing operations, resource management, stakeholder engagement, transformational priorities, talent management and performance excellence. Create, adapt, and execute CDQ strategic plans.

• Make key decisions that are guided by established strategies and priorities. Influence operating policies and procedures that affect key CDQ processes. Interpret enterprise-wide policies, processes and procedures that may affect teams and operational workflows.

• Build collaborative relationships and effectively interact frequently with CDQ stakeholders and Global AbbVie leaders. Interact with diverse groups within function and maintains strong working relationships with internal and external collaborators.

• Lead a Process Improvement & Optimization program for Commercial and Distribution Quality that connects CDQ functions enables them through innovative surveillance and enhancement of their pivotal quality systems.

• Drive global key performance indicators for quality internationally by ensuring appropriate systems are in place for escalation and compliance with quality management review visibility.

• Direct, govern and continuously develop a central Global Project Management Office for the Commercial and Distribution Quality organization.

• Direct continuous governance and surveillance of global training compliance, global change management compliance and global quality event reporting performance.

• Manage a team of quality professionals, setting performance expectations, providing feedback, development of staff and handling of personnel situations. Ensuring adequate resources and appropriate training to effectively support and meet changing business and compliance needs.

• Operate as part of the global AbbVie Medical Device network and ensure all requirements are met for AbbVie EU Authorised Representative (as defined in MDR 745, Art. 11 and Art. 15 and associated annexes) for all AbbVie Medical Devices.

• Consistently demonstrate AbbVie’s Ways of Working and Leadership Attributes including an enterprise mindset and people leadership. Effectively manage performance, provide timely feedback, appropriately reward, and recognize valuable achievement, develop talent, and create a succession pipeline. Understand and execute AbbVie's vision, goals, and strategies.

Qualifications

• Bachelor’s Degree or equivalent education and 10+ years of experience. Master’s degree preferred.

• Experience working in the pharmaceutical and medical device industry within FDA and EMA requirements.

• Experience working at an enterprise level engaging with executive business leadership.

• Expert understanding of Quality Management System design, development, and governance.

• Detailed knowledge of GxP requirements, industry best practice and current regulator expectations.

• Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical products.

• Experience in quality management system auditing is preferred.

• Proven managerial leadership of technical professionals and in leading cross-functional teams.

• Proven ability to drive outstanding employee performance and engagement through developing, coaching, motivating, energizing, and inspiring team members.

• Strong oral (with all levels of management) and written communication skills needed.

• Demonstrated success as a collaborative team player and have a broad, diverse, cross-functional, or cross divisional experience with the ability to think strategically and creatively.

• Strong people Manager with ability to lead high performing team of professionals.

• Solid interpersonal and influencing skills to ensure buy in at various levels and within and across various functions of the organization. Flexible, ability to organize and prioritize, results driven with little direction or supervision.

Additional Information

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.