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DIR, QUALITY

Job Title: DIR, QUALITY
Job Code: 2599
FLSA: E
Job Level: 16
Revised Date: 11/01/2020
Job Family: JF 28

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Occupational Summary

A quality professional who provides leadership and tactical input for defining quality strategy, implementing policies, key risk indicators and quality measures for clinical research. Oversees the development, implementation, and administration of Good Clinical Practice and Human Subjects Protections quality assurance and compliance systems, programs, and activities in service of DCRI's strategic goals. Drives transformational change and improvements within the quality culture in a highly-complex, rapidly-evolving regulated environment. Responsible for central administration of policies and SOPs and audit and GCP inspection programs. Is an expert resource and provides guidance regarding the interpretation and application of US and global regulatory requirements and quality standards to QARS staff, senior leadership, and faculty. Leads efforts to develop risk assessments, conduct trend analyses and facilitate process improvement activities.

Work Performed

Understand and leverage all quality aspects of the DCRI organization. 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 DCRIs 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 DCRIs Operational Leaders to provide quality guidance and feedback on key quality metrics and updates.

Ensure execution of DCRIs 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 with relevant business representatives to promote 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 other 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 updates, 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 of DCRI 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 well as updates to process and quality documents, etc. based on the DCRIs 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 DCRIs 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.

Responsible for 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.

Management of vendor and partner audits ensuring risk assessment, internal processes, and any project specific requirements are met.

Personnel Management

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 and 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.

Financial Management

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.

Required Qualifications at this Level

Education/Training

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

Experience

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.

Skills

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 teambuilding, 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.

Ability to 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


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.