Regeneron is currently looking for a Quality Compliance Specialist with a 1st shift, Monday-Friday, 8am-4:30pm schedule. This position will focus on internal change controls. The Quality Compliance Specialist ensures quality and compliance to cGMPs, internal, external, and international requirements with respect to change control activities.

As a Quality Compliance Specialist (Change Control), a typical day might include the following:

• Reviewing, assessing, editing, and approving change control documentation to ensure compliance with quality, regulatory and SOP requirements.
• Facilitating cross functional meetings and providing guidance and consultation to change control owners
• Developing relationships with end users and providing guidance on standard processes in Change Control
• Partnering with other members of the Quality Assurance team and/or end users of the system to Identify, Develop, and Implement Continuous Improvements to the Change Control System, Process, and associated procedures
• Interpreting compliance and regulatory requirements for incorporation into departmental systems, procedures and documentation.
• Supporting regulatory and customer audits.

This role might be for you if:

• Knowledgeable in Biotech/ Pharmaceutical Quality systems inclusive of cGMP, FDA regulations and familiarity with ICH guidelines and global regulatory.
• Demonstrated ability to perform independent work requiring attention to detail, accuracy and scientific judgment and a consistent record of shifting thought processes quickly from one task to another.
• Ability to comprehend, analyze and interpret process and systems information, technical procedures, reports and regulations to make decisions in a cGMP environment.
• Proven track record of establishing and maintaining effective working relationships with managers and employees as well as influencing individuals of various levels to gain understanding and/or acceptance of an idea, policy, procedure or plan.
• Possess excellent interpersonal, written and oral communication skills with the ability to use active listening skills to understand concerns or reasoning in order to be responsive, gain trust and build strategic relationships.
• Proficient digital literacy in Microsoft (MS) Word, Excel and PowerPoint required. Experience with Veeva/QMS preferred.

To be considered for the Quality Compliance Specialist position you must be willing and able to work Monday- Friday, 8am-4:30pm. You must have a B.S in Life Sciences, Engineering or related field. For various levels you must have the following:

• Associate Quality Compliance Specialist – 0-2+ years
• Quality Compliance Specialist – 2-5+ years
• Senior Quality Compliance Specialist – 5+ years

May substitute proven experience for education requirement. Experience in change control function strongly preferred. 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)

$62,355.00 - $128,700.00