- Track and manage quality of over 300 GMP, GLP, GCP, and ISO-regulated global vendors contracted by company.
- Enforce implementation of regulated clinical and commercial processes to fulfill compliance requirements.
- Provide effective leadership to cross-functional departments and coordinate multi-discipline project groups.
- Ensured compliance with company quality standards by conducting vendor and product evaluations.
- Supported senior management in informed decision-making by communicating KPIs and responding to queries.
- Cultivated and maintained working relationships with stakeholders and management team at all corporate levels.
- Quality management of 300+ GMP, GLP, GCP and ISO regulated global vendors used by the company. Quality management of 300+ GMP, GLP, GCP and ISO regulated global vendors used by the company.
Skills:
Biopharmaceuticals, Contract Manufacturing, ICH, cGMP manufacturing, ISO 9001, ISO 13485, Good Distribution Practice (GDP), Data Integrity, 21 CFR Part 11, 21 CFR Part 210/211, Change Control, Compliance Regulations, Corrective and Preventive Action (CAPA), Standard Operating Procedure (SOP), Master Control, SharePoint, SmartSheet, Project Management, Time Management, Organization Skills, Team Management, Cross-functional Team Leadership, Veeva, Microsoft 365 Suite, FDA Bioresearch Monitoring Information (BIMO), Master Control