QA Compliance Expert - Regulatory CMC Facilitator
Core
Partner with regulatory teams to align Chemistry, Manufacturing and Control (CMC) strategies across the product lifecycle and support compliant change control decisions.
Role type
Senior QA Compliance Expert (Regulatory CMC)
Builds
Regulatory compliant biologic drug substance manufacturing processes
Domain
Pharmaceutical industry, Biologics
Deliverable
Dashboards & analysis
Required skills
CMC strategy alignment, regulatory change control evaluation, quality event investigation support, audit preparation, process harmonization, training delivery
Preferred skills
Knowledge of recombinant protein manufacturing, nucleic acid manufacturing
Technologies
None stated
Responsibilities
Partner with regulatory teams to align CMC strategies; Evaluate product changes for regulatory impact; Serve as primary site contact for regulatory matters; Provide guidance during quality events and investigations; Coordinate CMC documentation reviews; Support regulatory inspections and audits; Drive compliance initiatives; Deliver training on regulatory awareness
Seniority
Senior, hands-on IC