Duke University Job Description: ASSOC DEAN & EXEC DIR REG AFFAIRS &QLITY (3813)

Occupational Summary

Directs, manages, and supervises all activities within the Duke University School of Medicine (SOM) Office of Regulatory Affairs and Quality (ORAQ), including numerous collaborations, such as Duke University Hospital (DUH) and Duke Clinical and Translational Science Institute (CTSI). ORAQs responsibilities include regulatory and GMP quality oversight of data/IT requirements, such as FISMA and 21 CFR Part 11, and medical products regulated by the U.S. Food and Drug Administration (FDA). ORAQ oversees approved products sponsored by Duke University and oversees the use of unapproved, or investigational, medical products in research studies. To ensure compliance with federal regulations, ORAQ facilitates review of certain contracts for IT regulatory concerns, provides guidance on regulatory strategy, preclinical testing, and product manufacturing; supports FDA meetings and inspections; prepares, submits and maintains regulatory applications; reviews proposed Transfer of Regulatory Obligations to the University, and develops and administers institutional education and training programs. Through GMP quality oversight, ORAQ works closely with manufacturers on campus to ensure compliance with current Good Manufacturing Practices (cGMP) and assists investigators with implementing these requirements, including creation and review of SOPs/batch records, review and execution of quality agreements, analytical testing of products and materials, and release of products for commercial and/or clinical trial administration.

ORAQ authors, reviews, submits, oversees, and maintains FDA regulatory applications and quality assurance documentation relating to investigational medical products used in clinical and/or non clinical research studies at Duke or manufactured within a current Good Manufacturing Practice (GMP) facility on campus. The Executive Director is responsible for developing, coordinating and maintaining systems and procedures that support compliance with federal regulations, guidelines, and applicable laws as well as Duke Universitys mission for research with investigational medical products. The Executive Director serves as Dukes senior authorized representative in FDA Agency interactions and acts as ORAQs lead representative in internal University discussions. This position will develop a vision and strategy for GMP quality assurance and regulatory affairs at Duke and set a high standard for this environment. This person will provide leadership and direction through managers and senior professional staff within the office.

Work Performed

Oversees all aspects of ORAQ.

Directs, manages, and supervises all of ORAQs regulatory affairs (RA) and GMP quality assurance (QA)/quality control (QC) operations, including, but not limited to, managing applicable IT regulatory compliance (ex. FISMA) and the drafting, review, submission, and maintenance of FDA regulatory applications and quality documentation to ensure compliance with federal regulations, guidelines, and applicable laws as well as Duke Universitys mission for research with investigational medical products.

Oversees GMP quality management system(s) and standard operation procedure (SOP) requirements for investigational medical products manufactured on campus, for Duke sponsored clinical trials (as applicable), or within a Duke cGMP manufacturing facility. Serves as an institutional signatory for quality agreements, in conjunction with review by the Office of Research Contracts.

Interacts effectively, collaboratively, and transparently with other offices at Duke, including SOM leadership, providing strategic guidance and support for regulatory and cGMP quality assurance questions or projects.

Works effectively with a cross functional team to achieve university, office, and faculty specific project goals.

Interfaces with Duke faculty/leadership/study teams, GMP facilities, and regulatory agencies to address identified issues.

Reviews and monitors regulatory and quality assurance trends and reports and escalates risks to SOM leadership and/or other offices at Duke, as applicable.

Serves as the primary point of contact for FDA GMP inspections of Duke manufacturing facilities.

Interfaces with FDA inspectors, along with regulatory officials, auditors, and/or external customers for other GMP audits and inspections.

Responsible for drafting, reviewing, and submitting responses to inspectional observations as well as critical or GMP related communication with the FDA or other external entities.

Serves as Dukes senior authorized representative in FDA Agency interactions and acts as ORAQs lead representative in internal University discussions regarding FDA regulatory affairs or GMP quality assurance questions/inquiries.

Provides strategic direction on regulatory affairs and cGMP quality assurance matters to SOM leadership and drives implementation of new initiatives throughout the University.

Develops, deploys, and executes policies, objectives, and plans that align and support University goals.

Directly supervises ORAQ senior staff and managers along with the administrative support personnel for ORAQ operations.

Plans and directs resources and activities that support regulatory affairs and GMP quality assurance needs across Duke.

Oversees personnel actions including, but not limited to, hiring, training, performance management, work assignments, and promotions.

Develops action plans with direct reports to ensure the continued success of the office and to ensure work is completed effectively, accurately, and on time.

Mentors, coaches, and manages direct and indirect reports to foster professional development and retention of talent.

Develops regulatory affairs and cGMP quality assurance organizational structures and functions that support the use of investigational medical products in research studies and continued production and compliance of FDA approved products sponsored by Duke University.

Creates long term plans to sustain ORAQ support of product development and manufacturing by evaluating established systems and resources and projecting needs to ensure continued compliance.

Establishes and maintains effective relationships with regulatory agencies, especially the US FDA.

Interfaces with regulatory and quality assurances leadership at other academic medical centers to collaborate and pursue opportunities for funding, support, and educational initiatives.

Collaborates with ORAQ, Duke, and externally on publications related to the clinical research supported and/or regulatory and quality initiatives/projects.

Produces, in collaboration with the School of Medicine senior administration, the ORAQ annual budget.

Ensures overall operation is within the approved budget and timeline.

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.

Required Qualifications at this Level

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 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.