Director/Senior Director, Quality Assurance cGMP
Director/Senior Director, Quality Assurance (cGMP focused)
Remote based in East Coast (preferrably Northeast)
- Function as QA cGMP Lead and provide global quality assurance strategies for global product development.
- Have thorough knowledge of cGMP, FDA guidances, EU Directives, and ICH GxP. Familiar with current and emerging US and global guidelines and regulations and apply to the company's quality management plan and risk mitigation strategies.
- Ensure company and the contracted manufacture ready for health authority (HA) inspections, and host HA inspections.
- Perform risk assessments to identify audit targets, establish audit plan, conduct internal, vendor and contracted manufacturer audits, develop and maintain audit tools, checklists, and author audit reports and other audit-related documentation.
- Provide strategic direction for GMP activities. Work with relevant functions for quality issues and CAPAs. Ensures timely communication of critical QA issues including critical audit findings, potential misconduct or issues of significant deviation to stakeholders and management.
- Define and execute overall quality assurance management in collaboration with QA GCP, Clinical and CMC departments.
- Define and implement global health authority inspection strategies in support of regulatory submissions and GMP compliance.
- Must have 8+ years of pharmaceutical or biotech industry experience
- Must have 6+ years of hands-on quality assurance lead experience for development products in GMP. Experience with small molecule is preferred.
- Experience in leading manufacture site and vendor audit is essential
- Experience in preparing and leading FDA and other health authorities' GMP inspection is a must
- Experience with overseeing Contracted Manufacture Organization is highly desirable
- Ability to adapt to a global, fast-paced, matrix, timeline driven environment with the competency to work independently and multi-tasking