Regeneron is hiring a Manager, QA Validation Oversight to lead a team dedicated to ensuring the integrity of our process validation processes. This role is integral in supporting process validation activities, ensuring global consistency, addressing recurring themes in process documentation, and playing a pivotal role in regulatory inspections and compliance.
In this role, a typical day might include the following:
Ensuring alignment between validation activities and Process Sciences initiatives to support successful transition of processes from development to manufacturing.
Collaborate closely with internal Process Sciences team to provide technical expertise and ensure consistency in Process Validation strategies.
Presenting/defending validation strategies, documentation, and processes to FDA and other regulatory agencies.
Reviewing and approving process validation documents, procedures, and protocols, proposing modifications and corrections where necessary to meet regulatory requirements and expectations.
Overseeing all aspects of QA Validation including review and approval of failure investigations, change controls, SOPs, Validation protocols and summary reports, and validation master plans.
Conduct one-on-one discussions with team members to review their performance feedback and set development goals, fostering professional growth within the team.
This role might be a for you if you:
Bring hands-on validation experience in a GMP-regulated environment.
Possess deep understanding and expertise in Process Validation.
Enjoy building strong, collaborative relationships across global internal teams.
Have a continuous improvement mindset.
Are an experienced leader who inspires and guides a multi-tiered team.
To be considered for this role, you must hold a Bachelor’s degree in Engineering, Chemistry, or Life Sciences degree and the following minimum years of experience for each level:
Associate Manager: 6+ years
Manager: 7+ years
May substitute relevant experience in lieu of education requirement. Level is determined on qualifications relevant to the role.
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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)
$90,800.00 - $173,400.00