Director, External Manufacturing Compliance

We are currently looking to fill a Director of External Manufacturing Compliance position. This position will supervise a team that supports the various compliance activities associated with all products manufactured in Regeneron’s External Manufacturing network in accordance with mandated regulatory requirements, Regeneron Quality Systems, and site expectations.

This position is located at our Manufacturing facility in the Albany, NY area. This is a fully onsite role.

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

• Provides leadership and support to prioritize, resource, guide, strategize and deliver upon compliance requirements
• Establish standard processes in all compliance related activities, collaborate and partner with quality compliance groups, strategically meet goals and lead External Manufacturing cGMP Policies and SOPs
• Leads and prioritizes operations and practices for supporting CMO and/or Partner Change Notifications, Change Controls, SCAR’s, Deviations and CAPA’s for clinical and commercial manufacturing across External Manufacturing
• Provides performance metrics status and continuous improvement needs to CMOs at regular Operations Steering Committees
• Is responsible for Inspection Readiness strategies in relation to any regulatory inspection or quality audit involving outsourced manufacturing, provides advice and on-site support to CMO /Partner sites during regulatory, provides support to internal Regeneron audits
• Provides expertise to the global External Manufacturing organization on cGMP compliance standard processes, as well as, new and developing cGMP regulatory requirements and trends
• Develops, trains and coaches Compliance and Manufacturing Specialists to lead or support closure of Quality System records
• Collaborates with Quality Assurance, External Manufacturing teams to effectively address observations and drive CAPAs, SCAR’s, CC’s to completion
• Travel up to 40% is required (domestic and international)
  
  

This Role May Be For You If You

• Demonstrate a proactive approach to issue resolution with an ability to work well across various departments as well as business partners
• Have excellent interpersonal, cross-cultural, communication and problem-solving skills
• Possess experience interacting with Contract Manufacturing Organizations and leading in the Compliance/QA/QC field
• Have knowledge of industry practices and regulations (cGMP, Annex I) and across multiple health authorities (e.g. FDA, EMA, MHRA, etc.).
• Are a leader committed to team growth and staff development
• Proficient in German, French and/or Spanish (oral and written) is a plus.
  
  

Role

To be considered for this role you must hold a Bachelors degree and the following amount of pharmaceutical aseptic manufacturing experience in compliance, quality assurance or manufacturing related roles, for each level:

• Director – 12 years
• Sr Director – 15 years
  
  

May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

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)

$200,000.00 - $333,400.00