Regeneron is hiring! As the Director of Quality Technical Operations you will lead a high-impact Quality function spanning QA MES, QA Validation Oversight, and QA Tech Transfer. You’ll define and implement cGMP best practices, set quality standards and metrics, and ensure clinical and commercial manufacturing operations meet and exceed regulatory compliance requirements.
In this role, a typical day might include the following:
Define and implement quality standards, systems, and metrics across clinical and commercial manufacturing operations.
Provide quality oversight to activities related to validation and ensure that they are effectively administered and comply with regulatory requirements.
Oversee QA tasks related to electronic manufacturing record management and tech transfer.
Compile, organize, and present quality metrics and trends to senior leadership.
Plan and allocate QA resources to meet program goals, timelines, and priorities.
Coordinate prioritization of activities with area management to optimize execution.
Prepare for regulatory and customer audits; ensure observations are addressed effectively and on schedule.
Maintain safety and operational standards and approve documents related to QA functions.
This role might be for you if you have:
Proven leadership in cGMP environments with hands-on experience in QA systems and metrics.
A track record of successful audit readiness, execution, and response management.
Strong collaboration, communication, and stakeholder engagement skills.
An understanding of bulk API biologics manufacturing operations.
To be considered for this role you must hold a Bachelor’s degree in Life Sciences or related field and the following amount of relevant pharmaceutical manufacturing experience for each level:
Director – 12+ years
Sr Director – 15+ years
Level to be determined based on qualifications relevant to the role. May substitute proven experience for education requirement.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
Salary Range (annually)
$172,200.00 - $338,400.00