GMP Change Control Specialist — CAPA & Compliance Lead

Regeneron Pharmaceuticals, Inc.; New York (NY); On-site; USD 62,000 - 129,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking Change Control Specialists to develop strategic plans for change control and CAPA implementation to support manufacturing operations under cGMP standards.

Roles include coordinating documentation, leading cross-functional meetings, mentoring teams, and presenting changes to senior leadership across manufacturing domains. On-site roles span Bulk Drug Substance, Technical Operations, and Fill/Finish Manufacturing.

Qualifications

• BS/BA in Life Sciences, Engineering, or related field; or equivalent combination of education and experience.
• Associate Change Control Specialist: 0-2+ years of relevant experience
• Change Control Specialist: 2+ years of relevant experience
• Senior Change Control Specialist: 5+ years of relevant experience
• Level will be determined based on experience

Responsibilities

• Craft business plans to advance 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 defines scope, impact, risk, and regulatory considerations
• 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 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

Skills

Change control

CAPA

cGMP

Regulatory compliance

Education

BS/BA in Life Sciences, Engineering, or related field

Job description

Regeneron Pharmaceuticals, Inc. is seeking Change Control Specialists to develop strategic plans for change control and CAPA implementation to support manufacturing operations under cGMP standards.

Roles include coordinating documentation, leading cross-functional meetings, mentoring teams, and presenting changes to senior leadership across manufacturing domains. On-site roles span Bulk Drug Substance, Technical Operations, and Fill/Finish Manufacturing.