Senior Corporate Counsel, Global TechOps & Pharma Quality
Core
Senior Corporate Counsel providing global regulatory and transactional legal support for Pharma Manufacturing units, focusing on FDA/cGMP compliance, manufacturing agreements, and quality governance.
Role type
Senior Corporate Counsel (Pharma Manufacturing & Regulatory)
Builds
Manufacturing supply and development agreements, quality governance structures, compliance frameworks for internal and external partners
Domain
Pharmaceutical/Biotech Manufacturing & Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
US FDA/cGMP regulatory counseling, manufacturing supply agreement structuring, quality system compliance, external partner (CMO/CDMO) oversight, outside counsel management, risk management for regulatory enforcement
Preferred skills
Additional European languages (German, French, Dutch), cross-cultural sensitivity
Technologies
None stated
Responsibilities
Advise on global regulatory compliance (FDA/EMA) and manufacturing practices; Partner with Quality/Regulatory heads on quality governance and change control; Provide strategic advice on FDA/foreign health authority inspections and GMP audits; Address critical quality issues and supply interruptions; Structure quality agreements for external manufacturing partners; Manage retained outside counsel
Seniority
Senior, hands-on IC