Sr Dir GD Quality Management (GVP)

Regeneron Ireland DAC; Dublin; On-site; EUR 100,000 - 125,000; Full time

Job summary

A leading global pharmaceutical company is seeking a Senior Director for Global Development Quality Management in Dublin. This role involves leading quality initiatives, ensuring compliance in drug development, and fostering innovation. Ideal candidates will have extensive quality management experience and the ability to lead cross-functional teams effectively. The position offers an opportunity to make a meaningful impact on the company's mission in healthcare.

Benefits

Health and wellness programs

Fitness centers

Equity awards

Annual bonuses

Paid time off

Qualifications

• Extensive experience in quality management, primarily in GVP, GCP, and regulatory affairs.
• Strong track record of leadership in global functions.
• Expertise in risk-based quality management and inspection readiness strategies.

Responsibilities

• Lead the GDQM (GVP) sub-function, providing strategic direction.
• Collaborate with teams to support Good Pharmacovigilance and Good Clinical Practices.
• Drive process improvement initiatives and champion innovation.

Skills

Strategic thinking

Leadership of cross-functional teams

Risk management

Exceptional communication skills

Resource management

Job description

Overview

Join us as we shape the future of healthcare through innovation, integrity, and excellence. We are seeking an experienced leader to take on the role of Senior Director, Global Development Quality Management (GVP). This pivotal position offers the opportunity to drive strategy, lead quality initiatives, and collaborate globally to ensure compliance and excellence in drug development and pharmacovigilance practices. As a member of the GDQGO Leadership Team, you will play an integral role in advancing our mission while fostering innovation, quality, and collaboration across global functions.

Responsibilities

• Lead the GDQM (GVP) sub-function, providing strategic direction and operational oversight.
• Ensure proactive, risk-based approaches to quality and compliance within Regeneron\'s Quality Management System (QMS).
• Collaborate with cross-functional teams to support Good Pharmacovigilance Practice (GVP), Good Clinical Practice (GCP), and Medical and Regulatory Affairs.
• Oversee timely issue escalation, risk management activities, and inspection readiness.
• Manage team resources, including hiring strategies, onboarding, and performance reviews.
• Represent the GDQGO sub-function during regulatory inspections and cross-functional forums.
• Drive process improvement initiatives and champion innovation to enhance quality objectives.

Qualifications

• Are a strategic thinker with expert knowledge in GVP Quality and local affiliate QMS oversight.
• Have a proven ability to lead cross-functional teams and build strong stakeholder relationships.
• Thrive in a collaborative environment and are skilled at balancing strategic vision with operational execution.
• Are adept at identifying risks and embedding proactive quality management approaches.
• Possess exceptional communication skills and can effectively deliver key messages to executive leadership and cross-functional teams.
• Excel at managing resources, fostering team growth, and driving large-scale quality initiatives.

To Be Considered

• Extensive experience in quality management, particularly in GVP, GCP, and regulatory affairs.
• A strong track record of leadership in global functions and cross-functional collaboration.
• Expertise in risk-based quality management and inspection readiness strategies.
• A passion for driving innovation and process improvement in quality systems.
• Preferred qualifications include familiarity with Regeneron\'s global PV system and experience representing quality functions during regulatory inspections.

Why Join Us?

At Regeneron, we believe in the power of collaboration, innovation, and a commitment to excellence. As the Head of Global Development Quality Management (GVP), you will have the opportunity to make a meaningful impact on our mission to bring life-changing medicines to patients worldwide.

Join us and be part of a team that exemplifies quality, integrity, and leadership in every interaction.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.

Equal Employment Opportunity

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company\'s business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.