The Global Regulatory Affairs and Quality Assurance team supports Avanir throughout the product development and commercial life cycle by providing appropriate knowledge/expertise/input, by communicating effectively internally and with external stakeholders and by ensuring that Avanir operates within relevant regulations.
As part of Quality organization, this position will work closely with Executive Director of Quality and other Functional Leaders and be responsible for planning, scheduling, organizing, communicating, conducting, and reporting for performing an independent QC-in of AVANIR GxP generated data from Clinical Data Management. In addition, this role will provide support for internal and/or external AVANIR GxP Audit Program.
ESSENTIAL JOB FUNCTIONS
- Closely work with Functional Leaders of Regulatory, Clincial, CMC, and Quality to develop audit plans/schedule and perform independent Quality Control audits of GxP data that are generated for Clinical Data Management.
- Document and issue Qc auditreports. Follow-up to ensure all items are corrected in a timely and effective manner.
- Manage post-audit activities and follow-up on any necessary corrective and preventive actions.
- Provide support by participating in AVANIR GxP Audit Program both internally and externally.
- Create, implement, and conduct training of AVANIR SOP’s regarding data QC-ing processes and requirements
- Gather and interpret regulatory intelligence, as well as evaluate internal practices, make recommendations for improvement and execute against action plans.
- Evaluate quality systems, processes, procedures and protocols for compliance.
- Track, trend GxP Audit KPI Metrics for QC-ing outcome.
- Escalate regulatory compliance risks to Quality Leadership to ensure that all issues are mitigated in a timely manner.
- 20% travel both domestically and internationally
- 7+ years of experience in pharmaceutical industry
- 5+ years of experience in GxP Data QC-ing, and GxP auditing.
- Working knowledge of FDA GMP regulatory requirements
- Must be able to effectively collaborate with others and work in a matrixed team
- Must be flexible, resourceful, and multitask efficiently
- Excellent project management skills is a must.
- Great communication both oral and in writing.