Compliance Specialist - Process Sciences
Core
Provide oversight of cGMP compliance, focusing on change controls and supplier change notifications to support manufacturing operations and regulatory timelines.
Role type
Compliance Specialist (Process Sciences)
Builds
Manufacturing operations and regulatory compliance for drug substances, products, and advanced therapies
Domain
Life Sciences / Pharmaceutical Manufacturing
Deliverable
client delivery
Required skills
cGMP compliance oversight, change control management, supplier change notification evaluation, cross-functional coordination, project monitoring, metrics communication
Preferred skills
Strategic planning for lifecycle management, continuous improvement initiatives, subject matter expertise in change control systems
Technologies
Change control and supplier notification systems
Responsibilities
Drive execution and real-time tracking of Process Sciences change controls and supplier change notifications, Develop strategic plans to support change control implementation of routine program lifecycle management activities, Evaluate supplier change notifications to determine whether proposed changes meet company standards, Coordinate and/or lead cross-functional meetings with multiple departments to drive change control implementation, Present business critical and regulatory impactful change controls to senior leadership, Independently monitor and progress multiple projects concurrently
Seniority
Associate (0-2 years) or Specialist (2+ years)
