The Senior Quality Assurance and Compliance Auditor position develops, implements, and conducts the spectrum of quality assurance activities for health-related products in working with senior staff. The position will be responsible for ensuring compliance with applicable regulatory requirements and industry standards, conducting audits and investigations including follow-up and corrective action planning and reviewing/analyzing data and documentation. The candidate will also be expected to assist in development of positive and proactive approaches to quality assurance compliance to ensure that quality policies, procedures, programs, systems and software meet applicable regulatory and validation requirements, and are consistent with internal Quality Assurance goals and initiatives. The position will also lead training of functional areas and assist in the development of training sessions as well as participating in regulatory agency inspections.
- Coordinates internal and external audits to comply with required regulations and standards as well as FHI 360 Policies and procedures.
- Develops audit specific work plans and timelines for review
- Provides training to functional areas and develops/assists with the development of training sessions.
- Ensures that a quality management system is updated and maintained and provides input on potential improvements to the system.
- Serves as the liaison with internal and external partners to ensure effective collaboration efforts.
- Participates on functional teams focused on process improvement.
- Addresses issues, defines and implements effective corrective action to adhere to compliance regulations.
- Coordinates follow up and corrective action planning for internal and external audits.
- Prepares audit reports to management and regulatory agencies and/or sponsors.
- Keeps current on and disseminates information regarding regulations and guidance.
- Performs other duties assigned.
- 5-8 years of experience with compliance according to regulatory standards.
- Articulate, professional and able to communicate in a clear, positive manner with clients and staff.
- GCP CRO/Vendor auditing, Clinical Laboratory Auditing, Internal or Process-based GCP Auditing, 21 CFR Part 11, Computer Systems Validation (CSV) auditing, ICH E6 experience, and clinical site auditing experience preferred.
FHI 360 fosters the strength and health of its workforce through a competitive benefits package, professional development and policies and programs that support healthy work/life balance. Join our global workforce to make a positive difference for others — and yourself.
Travel Requirements: 10%-25%