Quality Assurance Manager - GCP
This position is responsible for overseeing GCP/Clinical Quality Assurance activities with an industry leader in NASH/MASH Therapies. The main objective is to ensure the quality and compliance of clinical trials sponsored by a leading biopharmaceutical company focused on innovative therapeutics. This includes adherence to relevant GCP regulations, ICH GCP guidelines, company SOPs, and current industry standards and best practices. You will be partnering with the Sr. Director of Quality on this fully remote position.
Position Responsibilities:
- Establish and maintain clinical quality systems and processes to ensure adherence to GCP, FDA, EMA, and other global regulatory requirements, fostering a culture of quality from the initiation of clinical trials to ensure patient safety and data integrity.
- Collaborate across functions to apply a risk-based approach to compliance and participate in regular internal and external study team calls for ongoing quality oversight.
- Partner with external vendors to ensure compliance is upheld and following up on internal Quality Event investigations, deviations, Observations/Findings, CAPAs, etc. to ensure closure.
- Support and maintain the eQMS. Contributing to the annual audit plan and Quality Management Reviews.
- Ensure clinical trial vendors operate in compliance with all applicable procedures, study documents, regulations/guidelines through Qualification audits and oversight activities, and manage internal/external audits (vendor, site, document, system or process) and prepare or review audit reports.
- Review key documents such as IBs, Protocols/Amendments, Consents, TMF Plans, and support inspection readiness activities or provide assistance during global agency inspections.
- Perform additional tasks in support of GCP Quality activities, and stay updated on applicable global regulations, guidance's, and industry best practices.
Qualifications and Skills Required:
- 5+ years of experience in Clinical QA within the biopharmaceutical or CRO industry, with extensive GCP knowledge; GLP/Nonclinical/GVP experience would be a plus.
- Strong understanding of the cross-functional drug development process, including clinical trial functional operations, data management, statistics, etc., and ability to develop collaborative internal and external relationships.
- Business and operational acumen, including the ability to escalate issues to management, and interact with all levels within an organization.
- Experience in inspection preparation or supporting regulatory agency inspections, and eQMS systems
- BS in life sciences or relevant field.
