The Director/Senior Director, GxP Quality Assurance is rresponsible for establishing and leading Aveo’s Quality Management System (QMS) operations and ensuring compliance with Local, State, Federal, and International regulations and standards associated with GXPs and Quality Systems. The incumbent will lead the quality and compliance activities for Aveo’s pipeline candidates ranging from early to late stage clinical trials and potential commercial launch and prepare Aveo and its vendors for possible pre-approval inspections and ensure adherence to all GLP, GCP and GMP applicable regulations, and company policies & procedures.
This position reports to the Senior Vice President, Technical Operations.
- Lead the organization compliance and ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards for manufacturing and production.
- Responsible for the creation, review and modification of Standard Operating Procedures (SOPs)
- Performs evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external clinical, safety, quality, and regulatory standards.
- Establish and maintain companywide training program and manage training matrix.
- Identifies risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy them. .
- Performs GMP and GCP audits and risk assessments.
- BA/BS in Chemistry. Advanced degree a plus.
- Minimum 10 years of experience in biotech/pharmaceutical industry; 8 or more years of progressive management roles in quality assurance
- Experience with working with and qualifying external vendors
- Proactive and polished communication skills, both verbal and written
- Superb attention to detail
- Working knowledge in both GMP & GCP