Responsibilities
- Assist in maintaining the Quality Management System, including standard operating procedures, training programs, and corrective and preventive actions.
- Manage and process documentation for controlled documents as needed.
- Design and deliver training programs for staff and external consultants.
- Lead and facilitate client or sponsor audits and assist during regulatory inspections.
- Organize and carry out evaluations of prospective and active vendors, including performing vendor audits when necessary.
- Plan and execute internal audits of quality management systems.
- Conduct audits at investigator sites to ensure adherence to protocols and standards.
- Oversee audits of trial master files to verify completeness and compliance.
- Contribute to computer system validation initiatives and participate in change control procedures.
- Offer quality assurance guidance and support to internal and external project teams.
- Handle reported quality events and oversee related corrective and preventive action plans.
- Evaluate quality systems to identify compliance risks and recommend process improvements to QA leadership.
- Maintain quality and compliance tracking tools, databases, performance metrics, and recordkeeping systems.
- Adhere to relevant regulatory requirements and guidelines, including U.S. FDA, EU regulations, ICH standards, and internal policies.
Work Arrangement
Hybrid
Other
Willingness to travel up to 25% within the country or abroad.
