Quality Assurance and Regulatory Compliance Associate
The Quality Assurance and Regulatory Compliance Associate provides oversight for all quality assurance activities for the Duke Reading Center (DRC) and reports directly to the Director of the Duke Reading Center.
- Plan and perform internal audits of the DRC systems, processes, and programs for compliance with applicable regulatory and industry standards.
- Prepare audit reports and assist the DRC to develop corrective action plans.
- Monitor completion of corrective action plans.
- Plan and perform external audits of vendors for qualification assessment, including due diligence review, quality system evaluation and periodic re-evaluations;
- Prepare audit reports and respond to sponsor audit findings.
- Oversee the Compliance and Training Coordinator. Monitor completion of corrective action plans as required.
- Represent the DRC during audits conducted by external organizations including sponsors, CRO's and regulatory authorities.
- Develop and present seminars and/or Powerpoint-type presentations on regulatory compliance and audit participation
- Develop and continually improve a Quality Management System Develop and review standard operating procedures (SOPs)
- Provide guidance to develop DRC functional group SOPs and review them for regulatory compliance.
- Perform internal audits and conduct root cause analyses of complex quality issues, prepare trend analysis reports and recommends preventative and corrective actions to the Director.
- Stay current with regulatory, quality, and industry trends (particularly related to FDA, NIH, ICH and International regulations).
- Assist the Director and key personnel by developing recommendations for actions necessary to ensure quality deliverables and ongoing compliance.
Duke Entity MEDICAL CENTER
Job Family Level 14
Full Time / Part Time FULL TIME
Regular / Temporary Regular
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex,sexual orientation, or veteran status.
Duke aspires to create a community built on collaboration, innovation,creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Essential Physical Job Functions:
Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
Work generally requires a bachelor's degree in a biological Science.
Work requires six years of experience quality assurance or quality control related to clinical trials.A Master's degree in a related field may be substituted for 2 years of required experience.OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE