DIRECTOR, QUALITY ASSURANCE, DCRI

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.

Position Summary

Reports to the DCRI Executive Director and oversees the DCRI’s quality assurance team, this position leads and directs the establishment and maintenance of the Quality Management System for the DCRI providing strategic and tactical solutions across projects, networks and functional teams. Oversees the development, implementation and administration of all attributes of DCRI Quality Assurance including administration and application of Good Clinical Practice guidelines as well as regulatory requirements. Serves as an internal expert resource and provides guidance around the design and support of a quality infrastructure. Aligns and improves quality approaches through the use of established quality control processes. Oversees and executes quality re lated projects specific to the functions of the DCRI, includingadministr ation of DCRI Quality Study Documents (QSD’s) and audit/inspection readiness. Leads efforts to develop risk assessments, develop tre nd analyses/metrics, and facilitate process improvement activities across the Institute and report on those as a member of the Extended Operational Management Team.

Primary Responsibilities and Task

• Understand and leverage all quality aspects of the DCRI or ganization. Anticipate potential organizational and cultural barriers to success and identify how to turn them into supporters.
• Provides a clear vision for the organization and Quality Assurance Team, including future plans and direction based on the DCRI's strategic plan, industry trends, and the evolving regulatory requirements.
• Develops and implements regulatory compliance strategies and approaches based on knowledge of regulatory requirements and clinical research operations,expectations of regulatory agencies and sponsors, and industry best practices. Strives to balance cost and quality in assessing risk and making recommendations regarding compliance strategies. Works closely with DCRI’s Operational Leaders to provide quality guidance and feedback on key quality metrics and updates.
• Ensure execution of DCRI’s quality plans and processes including external and internal assessments, coordinating sponsor audit and Regulatory Inspections, support of Quality System Documentation and the Quality Incident program by promoting engagement through Quality Forums, Quality Gates and other mechanisms to allow for continuous quality improvement.
• Liaise and regularly maintain relationship withrelevant business representatives topromote quality initiatives within DCRI, across the Duke eco-system, and with external partners where appropriate. Fosters communication among staff to leverage the knowledge and expertise of individual group members and facilitate consistent responses.
• Represent Quality Assurance in client visits, audits and inspections.
• Knowledgeable resource to establish and maintain links between DCRI Quality and o ther parts of the DCRI as well as the broader Duke eco-system.
• Contributes to the development of strategic and tactical plan(s) for the Quality group. Align activities to the DCRI strategies, linking quality strategy to business outcomes and risks.
• Provide senior level support and consultation on matters related to quality, quality strategy and compliance. Champion the quality cause in areas of business to raise and maintain awareness of quality and quality standards. Serve as a member of the Operations Management Team (OMT) which provides a forum to discuss important quality initiatives, regulatory up dates, and allows for input into important operational decisions from a quality perspective.
• Act as driver and ambassador for quality, process improvement and standardization. Ensure active participation in quality, process change and improvement across DCRI.
• Assist in establishing systems and mechanisms for monitoring quality and compliance, including reporting quality trends and metrics to DCRI Senior Leaders, OMT , and staff.
• Identify,initiate and facilitate remediation of compliance gaps in Quality System Documentation. Works with functional group leaders to identify areas of highest risk and inconsistencies in internal systems and processes.
• Provide leadership in the implementation and oversight of training and qualification ofDCRI quality staff. Identify and mentor future Quality leaders in the DCRI.
• Stays abreast of evolving regulatory trends that are likely to impact the DCRl, advises senior leadership appropriately, and develops recommendations regarding the initiation of specific strategies and actions. Works closely with Duke Office of Regulatory Affairs and Quality to assure consistency in regulatory trends within Duke.
• Directs and implements training programs as wel l as updates to process/quality documents, etc. based on the DCRI’s needs and audit findings in order to support organizational compliance and quality improvement. Set a vision for change and create metrics and accountabilities to monitor assuring alignment with DCRI’s mission and strategic plan.
• Maintain a positive, collaborative, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner.
• Responsiblefor providing timely quality management reports, trend analysis and improvement recommendations across all levels of management. Work closely with senior staff to drive quality efforts deeper into the organization so everyone sees their role in expanding our level of quality.
• Will assume additional duties in support of quality operations as appropriate.
• Managementof vendor/partner audits – ensuring risk assessment, internal processes, and any project specific requirements are met.

• Contribute to performance plans, coaching and feedback, performance evaluations, and individual development plans
• Develops and implements orientation programs for new staff as well as ongoing training, education and professional development allowing for diverse opinions to be shared/heard.
• Conducts regular forums and meetings and ensures that Quality Assurance staff are kept abreast of organizational activities, goals, policies,and priorities. Provides appropriate opportunities for staff to provide input, obtain clarification, and express concerns in an open and transparent environment.
• Develops strategies and programs to foster the engagement and morale of Quality Assurance staff including employee reward and recognition initiatives, team-building, etc.
• Responsible for overall resource management of the Quality Assurance team.

• Responsible for Quality Assurance budget, forecasts for staff expenses (audit requirements, etc.), as well as ongoing oversight of expenses(managing to approved budget). Monitors expenditure of funds relative to budget, provides appropriate justification for variances, and ensures that appropriate interventions and escalation is implemented where necessary.

Other Duties

• Performs other related duties incidental to the work described herein.

Required Qualifications

Education/Training: (refer to the Duke HR website for minimum qualifications required if applicable)

• Bachelor Degree required. Candidates with Master Degree or Ph.D. in health, scientificor business discipline preferred.

Experience: (refer to the Duke HRwebsite for minimum qualifica tions required if applicable)

• A minimum of 10 years of progressively responsible experience in a biomedical research setting including CRO, pharmaceutical, medical device and biotechnology industries with a minimum of 5 years' management experience.

Knowledge, Skills and Abilities:

• Solid knowledge of applicable regulatory requirements including GCP, CFR Part 11, EU Directives, HIPAA, and ICH Guidelines as well as Quality by Design best practices.
• Strongly prefer candidates with extensive knowledge of FDA requirements related to clinical research.
• Strong leadership skills including team building, coaching, mentoring, and professional development of staff.
• Strong interpersonal skills to build effective collaborative relationships with a variety of stakeholders. Political savviness, diplomacy, and ability to effect change through influence, negotiation and persuasion.
• Ability to communicate constructive criticism in a tactful, supportive, persistent, and non-adversarial manner. Ability to facilitate situations involving conflict.
• Abilityto build trust and credibility by demonstrating the highest level of personal and professional integrity, commitment to ethical standards, diversity, and honest communication.
• Experience with process improvement and continuous quality improvement methodology.
• Strong organizational, problem-solving, facilitation, and prioritization skills.

Registration, Certification or Licensure:

• N/A

Bachelor Degree required. Candidates with Master Degree or Ph.D. in health, scientific or business discipline preferred.

A minimum of 10 years of progressively responsible experience in a biomedical research settings including CRO, pharmaceutical, medical device and biotechnology industries with a minimum of 5 years management experience.

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.