Regeneron
Senior Director GD Quality Standards & Continuous Improvement (GCP, GVP, GLP)
The Head, Global Development Quality Standards & Continuous Improvement (GDQSCI) will lead and support the GDQSCI sub-function, ensuring effective oversight of responsibilities and team management. As a member of the Global Development Quality Governance & Oversight (GDQGO) Leadership Team, this role involves overseeing the Global Development Quality Vault, ensuring robust Computer System Validation (CSV) and quality oversight for equipment and assay qualification activities, while promoting a culture of continuous improvement.
A Typical Day in the Role Might Look Like:
Plan and prioritize goals and projects aligned with the group's strategic vision.
Manage team resources, including hiring strategies and candidate endorsements.
Oversee staff management, including onboarding, performance reviews, and career development.
Attend GDQGO Leadership Team meetings, contributing to strategy and quality metrics discussions.
Lead process improvement initiatives and champion innovation for quality objectives.
Contribute to GDQ/GDQGO policies and ensure compliance with regulations and best practices.
Integrate quality risk management in processes where applicable.
Collaborate with other department leaders for effective quality oversight.
Represent senior management at quality forums and during regulatory inspections.
This Role May Be for You If You:
Have strategic leadership and technical expertise in the Quality Management System Framework, Quality Vault, Computer System Validation (CSV), and Quality Standards.
Can act as the primary Business Process Owner and Subject Matter Expert (SME) for the Quality Vault.
Are experienced in implementing new Veeva Vault Quality features in collaboration with the GD IT team.
Can assign super-users and SMEs for Quality Vault systems and lead operational and quality metrics development.
Oversee quality data stewardship and support inspection and audit activities.
Serve as an escalation point for significant Quality Vault issues to Executive Quality Leadership.
Participate in the governance and oversight of system vendors, including issue management.
Review and maintain CSV policies and artifacts, providing guidance on test failures.
Oversee quality reviews and approvals for equipment qualification artifacts and testing results.
Create and implement best practice quality strategies and policies with the GDQGO Leadership Team.
Champion the Quality Management System and enhance awareness within Global Development.
Lead governance activities and facilitate quality oversight forums.
Ensure reporting of quality-related metrics to support continuous improvement.
Oversee the Quality Event portfolio, providing SME guidance and support for root cause analysis and CAPA development.
Collaborate with leaders to define Quality System Metrics (KQIs/KPIs) for measuring QMS health.
To be considered for this role, you must have a BS with 14+ years of relevant experience, MS preferred.
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!
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.-based 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.
Salary Range (annually)
