QA Compliance and Regulatory Director
Core
Provide leadership at the site Quality Operations level to support strategic initiatives, product filings, and management of the site Quality System to ensure regulatory standards are adhered to.
Role type
Director of QA Compliance and Regulatory
Builds
High quality, compliant products for patients
Domain
Pharmaceutical/Biologics/Medical Device Manufacturing
Deliverable
client delivery
Required skills
GMP pharmaceutical/biologics/medical device manufacturing expertise, people leadership, strategy development, project management, risk management, inspection readiness, audit readiness, CMC filing support, client quality agreement ownership, facility support management, succession planning
Preferred skills
Lean Six Sigma Black Belt certification
Technologies
cGMPs, GXP, regulatory standards and guidelines
Responsibilities
Lead inspection readiness and execution for regulatory agencies and client audits; Lead internal self-inspection program; Support CMC filing and market expansion filings; Own client quality agreements; Own risk management programs; Manage facility support (pest control, engineering updates); Lead site management review program; Lead and develop a team of individuals
Seniority
Director, strategic leadership & team management
