School of Medicine:
Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.
Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.
Primary role:
Quality Assurance (QA) in a cGMP (current good manufacturing practice) environment is responsible for ensuring that components, intermediates, drug substance, and drug product are of the quality required for their intended use and that quality systems are maintained. The Associate Director of Quality Assurance will have a strong leadership role within Duke, the Office of Regulatory Affairs and Quality (ORAQ), and with other GMP quality assurance staff, which may include managing GMP QA staff, GMP QC staff, and/or other GMP functions. This position will serve as an expert resource and provide guidance regarding interpretation and applicability of US (and global as appropriate) GMP requirements. The position will work with ORAQ leadership to support the GMP programs at Duke University, including release of products/clinical trial material, assistance with deviation and event management, review of vendor qualifications, and oversight of component control and disposition. The Associate Director of QA will function as central point of contact and serve as a daily liaison for strategic issue resolution and oversight of major cGMP quality systems. This position will consult with manufacturing operations staff, as applicable/requested, to serve as a resource. This position reports to the Director, Quality.
Essential tasks/responsibilities:
In conjunction with ORAQ leadership but functioning independently:
The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
Education/training:
Required: Bachelor of Science or Bachelor of Arts degree Preferred: Master's degree or PhD
Experience:
Required: Minimum 5 years of experience in a GxP regulated environment. Leading projects and teams with measurable deliverable outcomes Experience in representing the QA Department at upper level management meetings and/or outside of the organization. Making QA decisions independently. Experience in representing department in audits and inspections. Managing team related projects. Experience in monitoring the overall effectiveness of the in place quality systems and gap analysis.OR ANY OTHER EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
Skills:
Required:
Preferred:
Special competencies/credentials:
Preferred: Preferred certified Quality Auditor and/or RAC Certified
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description
Duke 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 essentialjob 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.
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