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DIR, QUALITY BY DESIGN
Job Title: DIR, QUALITY BY DESIGN
Job Code: 1837
Job Level: 16
Revised Date: 12/01/2016
Job Family: JF 28
Provide strategic and tactical consultancy to the DCRI Functional Quality Managers within the Quality By Design organization. Oversees the development, implementation and administration of the DCRI Quality By Design strategy. 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 gates and assessments. Oversees and executes quality related projects specific to the functions of the DCRI. Leads efforts to develop risk assessments, conduct trend analyses and facilitate process improvement activities.
Knowledgeable resource to establish links between the QBD-based part of the quality organization, DCRI Quality and other parts of the DCRI. Understand and leverage 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 Quality By Design group, including future plans and direction based on the DCRI's organizational goals, industry trends and the evolving regulatory landscape. Stays abreast of overall trends in the field of clinical research in both industry and academic environments including but not limited to Quality by Design.
Develops annual goals and objectives for the Quality By Design group and ensures alignment with the organization's mission, vision and values. Participates in the development of DCRI-wide strategic plans. Act as driver and ambassador for quality, process improvement and standardization (e.g. Operational Optimization & Innovation). Ensure functional Quality Manager participation in quality, process change and improvement.
Assist in establishing mechanisms monitoring quality and compliance, including reporting.
Identify, initiate and facilitate remediation of compliance gaps in procedures. Works with functional group leaders to identify areas of highest risk and inconsistencies in internal systems and processes.
Assist in implement monitoring controls for identification of preventive action opportunities (CAPA). With the support of the Organizational Learning Department, directs and implements training programs based on the DCRI???s needs and audit findings in order to support organizational compliance and quality improvement.
Identify and mentor future Quality leaders in the DCRI.
Champions and leads change by setting a vision for change and create metrics and accountabilities to align with the change.
Responsible for providing timely quality management reports, trend analysis and improvement recommendations for the Functional Group Quality Managers to senior management. Contributes to the development of strategic and tactical plan(s) for the Quality groups. Align activities to the DCRI strategies, linking quality strategy to business outcomes. 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.
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. Ensure implementation of DCRI Quality Strategy including Quality Forums, Quality Gates and other mechanisms to improve the quality infrastructure. 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.
Identifies and makes recommendations regarding equipment (capital and non-capital), facilities, and space required to support the Quality by Design effort.
Assists with budgetary forecasts for staff expenses (operating and capital) on an annual basis. Monitors expenditure of funds relative to budget, provides appropriate justification for variances, and ensures that appropriate interventions are implemented.
Determines the number, mix and expertise of Quality By Design staff needed to optimally perform all activities.
Contribute to performance plans, coaching and feedback, performance evaluations, and individual development plans.
Develops and implements orientation programs for new Quality By Design Functional Leads as well as ongoing training, education and professional development.
Conducts regular forums and meetings and ensures that Quality By Design staff are kept abreast of organizational activities, goals, policies, and priorities. Provides appropriate opportunities for staff to provide input obtain clarification, and express concerns.
Develops strategies and programs to foster the engagement and morale of Quality by Design staff including employee reward and recognition initiatives, team-building, etc.
Liaise and regularly maintain relationship with relevant business representatives to promote quality initiatives (e.g. Vendor Management and Customer Satisfaction Survey process). Fosters communication among staff to leverage the knowledge and expertise of individual group members and facilitate consistent responses.
Represent Quality By Design in client visits, audits and inspections. Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner.
Required Qualifications at this Level
Bachelor???s Degree required. Candidates with Master???s 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.
Solid knowledge of applicable regulatory requirements including GCP, Part 11, EU Directives, HIPAA, and ICH Guidelines as well as Quality By Design best practices. Strongly prefer candidates with knowledge of both FDA and government requirements.
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.
Ability to build trust and credibility by demonstrating the highest level of personal and professional integrity, commitment to ethical standards, 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.
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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.