Associate Director, Local Affiliate Quality Management Lead

The Regeneron Associate Director, Local Affiliate Quality Management Lead (LA QML) is a key position that will drive quality in local affiliate operations by providing expert-level guidance and leadership for all aspects of quality and compliance within the Regeneron QMS. We feel the Associate Director will apply sophisticated interpersonal and communication skills, to work on diverse, complex matters. This involves analysis of issues, data, processes, and situations and requires advanced knowledge of local affiliate operations, pharmacovigilance and issue management. We feel that this individual will act as a key interface between Regeneron global operations and local affiliates in all matters relating to the quality of GCP, GVP, Medical Affairs and Regulatory Affairs, supporting a cohesive culture of quality and compliance. We expect the QML will create strategic partnerships and direct risk-based quality management activities with key partners impacting the local and global quality management system supporting multiple departments. This will involve making independent decisions when implementing new projects and supporting technical/operational processes which are reported to executive level management. Furthermore, the Associate Director, LA QML will be responsible for supporting inspection readiness at the local affiliates at all times. This role will partner with other members of the Global Development (GD) Quality department to own the identification of trends through metrics in order to diagnose and remediate systemic quality issues.

In this role, a typical day might include the following:

• Act as a key quality expert in the establishment and maintenance of local affiliate office processes, supporting the alignment of Regeneron quality and compliance strategy and operations across all regions and in collaboration with key business partners (Global Patient, Safety, Medical Affairs, Regulatory Affairs, IOPS, Commercial, etc.)
• Lead and implement Change Management programs resulting from organizational and process changes impacting local affiliates
• Establish a proactive culture of continuous improvement to align with business objectives across all local affiliates
• Collaborates with affiliate sites, regional organizations, and global functions to ensure the vision and strategies for quality & compliance development and integration in line with applicable regulatory requirements are applied at the local country-level
• Collaborates with affiliate sites, regional organizations, and global functions to integrate and implement quality standards, systems, and strategies
• Ensures the integration of appropriate risk management principles in the development and maintenance of processes at affiliate offices

This role might be for you if:

• You have skills in taking initiative and working independently across multiple areas.
• You can make decisions on sophisticated issues under minimal guidance that have a significant impact on business operations related to PV.
• You are self-motivated with the ability to work optimally and provide mentorship to others in a multifaceted environment with ambiguity.

To be considered, we are looking for individuals with at least 8 years of Quality experience within the Life Science industry including previous lead experience. We expect individuals to be onsite a couple days a week at one of our offices.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$148,100.00 - $241,700.00