Director, Quality Technical Operations

Regeneron Pharmaceuticals • Rensselaer, IN

3d • Onsite

About The Position

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 have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location. 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) $172,200.00 - $338,400.00 Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

Requirements

• 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
• May substitute proven experience for education requirement.

Responsibilities

• 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.

Benefits

• health and wellness programs (including medical, dental, vision, life, and disability insurance)
• fitness centers
• 401(k) company match
• family support benefits
• equity awards
• annual bonuses
• paid time off
• paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Director