We are currently looking to fill a Principal Change Control Specialist position supporting our new fill finish facility. This position develops strategic plans related to change control and the implementation of robust corrective actions to support manufacturing operations by applying function expertise.
In this role, a typical day might include the following:
Crafts business plans to independently advances change control initiatives to implement Corrective and Preventative Actions (CAPA’s) and process improvements in support of manufacturing operations.
Assesses complex proposed change controls to evaluate if proposal satisfies company standards.
Organizes and prepares change control documentation that assesses and defines the scope, impact, risk, and regulatory impact associated with the change.
Reviews, edits, and revises controlled documentation in accordance with cGMP standards.
Independently coordinates and/or leads cross-functional meetings with multiple departments to drive change control implementation.
Provides advice and guidance to cross-functional teams to enable successful and GMP compliant change controls.
Independently monitors and progresses multiple projects concurrently – identifying, addressing, and/or raising potential obstacles in a timely manner.
Presents business critical and regulatory impactful change controls to senior leadership.
Independently performs advanced troubleshooting to identify and implement solutions to obstacles encountered during the change control process.
Leads projects and participates in quality driven business initiatives.
Works cross-functionally to develop and propose streamlined implementation strategies for change controls of increased complexity.
Guides and mentors others on the change control process.
Develops strategies to streamline the ways of working; uses metrics/data to present findings and recommendations to management.
Documents all training.
Assists with the training of new employees.
May manage direct reports.
This role might be for you if you:
Excel in a quality driven organization.
Can manage multiple assignments and changing priorities through robust organizational, planning, and project management skills.
Have a strong attention to detail.
Have strong technical writing and interpersonal communication skills.
Enjoy working in a fast-paced environment.
Have experience navigating a controlled quality system (preferred but not required).
To be considered for this role you must hold a Bachelor’s degree in Life Sciences, Engineering or related field and following minimum amounts of relevant experience for each level:
Associate Specialist – 0-2 years
Specialist – 2+ years
Senior Specialist – 5+ 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 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)