Change Control Specialist (Technical Operations)

We are currently looking to fill a Change Control Specialist position in our growing Technical Operations Compliance team. 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:

• Craft business plans to independently advances change control initiatives to implement Corrective and Preventative Actions (CAPA’s) and process improvements in support of manufacturing operations

• Assess sophisticated proposed change controls to evaluate if proposal satisfies company standards

• Coordinate and prepare change control documentation that assesses and defines the scope, impact, risk, and regulatory impact associated with the change

• Review, edit, and revise controlled documentation in accordance with cGMP standards

• Coordinate and/or lead cross-functional meetings with multiple departments to drive change control implementation

• Provide advice and mentorship to cross-functional teams to enable successful and GMP compliant change controls

• Independently monitor and progress multiple projects concurrently – identifying, addressing, and/or raising potential obstacles in a timely manner

• Present business critical and regulatory impactful change controls to senior leadership

• Document all training

• Assist 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

• Sr 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 step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

 

Where necessary, we disclose salary ranges for roles in all countries in which we operate.  The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.  Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.  If you have any questions, please speak with your recruiter. 

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$67,400.00 - $110,000.00