Director Quality Management

Director Management SystemsDurham, NC Responsibilities: Provides thought leadership to the entire organization on Quality- related standards, methods, and processes. Responsible for all Quality-related activities including quality assurance, compliance, and M&A due diligence and integration Sets strategic programs for implementing phase-appropriate quality standards/Quality Management System and practices Oversees supplier qualification and audit and inspection readiness; implements Quality Agreements where appropriate Counsel, train and interpret regulatory requirements to ensure company is in compliance at all times, conduct annual regulatory training for GCP/GMP, as required. Develop and maintain systems, practices, and processes to ensure quality and compliance; develops and maintains audit program and audit schedules Provide leadership and direction for significant deviation and CAPA events that may impact compliance status or incur significant business risk Qualifications Bachelor’s Degree required Experience with CMC or related environmentsSmall biotech/startup experience is required 15+ years of experience in quality, regulatory and compliance affairs Auditing experience required within GCP and GMP environments Training and QMS development/implementation experience required