Quality Compliance Specialist - Change Control

The QA Change Control Department is hiring! We are currently looking to fill a Quality Compliance Specialist, specific to 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 proposal owners
• Developing relationships with end users and providing advice 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 GMP 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 Process Compliance/QUMAS heavily preferred.

To be considered for the Quality Compliance Specialist position you must have a Bachelor’s in a scientific or engineering subject area or related field with the following minimum amounts of relevant experience for each level, in a combination of quality, production, engineering, regulatory (chemistry, manufacturing and control) and/or laboratory, with demonstrated accomplishments in effectively implementing cGMP requirements.

Associate Specialist – 0-2+ years
Specialist – 2-5+ years
Senior Specialist – 5+ years

Experience in change control function strongly preferred. Level is determined based on qualifications relevant to the role.

#REGNQA #LI-Hybrid

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$54,400.00 - $117,600.00