Research - Laboratory/Non-Laboratory, Staff/Administrative
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Department: 110313 - IR-4 Project
Location: Raleigh, NC
Essential Job Duties:
The IR-4 Project's National Quality Assurance Unit Manager will report directly to the IR-4 Project Executive Director. This position serves as the Chief Compliance Officer for the National IR-4 Project. This position is critical to the successful of the National IR-4 Project. IR-4 currently conducts approximately 80% of its research under the United States Environmental Protection Agency's (EPA) Federal Good Laboratory Practice Regulations (GLPs – as documented in Chapter 40- Code of Federal Regulations, Part 160).
The National Quality Assurance Unit Manager/Chief Compliance Officer is responsible for the two phases of the IR-4 GLP compliance program; (1) the appropriate training of scientists/research participants to achieve compliance and (2) detailed monitoring and assessment of GLP compliance during research. Specifically, this position has responsibilities to lead and manage the IR-4 Project's national Quality Assurance Unit (QAU) of certified Quality Assurance professionals . This position will take a key role in primary and continued training of the 120 IR-4 employees to meet the requirements of the GLPs via training programs. This position will participate in the development and implementation of IR-4 Project Standard Operating Procedures and policies. The National Quality Assurance Unit Manager/Chief Compliance Officer will be an integral part of the IR-4 Project Headquarters leadership team.
National Management of IR-4's Quality Assurance Compliance Activities (50%):
Working with the IR-4 certified Quality Assurance professionals and consultants (QAU) who are located throughout the United States, the IR-4 National Quality Assurance Manager shall:
Lead IR-4's annual National Quality Assurance planning meeting to develop assignments for QAU to perform field in-life inspections. Monitor progress and adjust QAU's assignments when necessary. Seek the retention of contract Quality Assurance professionals when conditions dictate.
Responsible to assure that IR-4 Project's Master Schedule is available to study participants, IR-4 Management and EPA Auditor and contains up-to-date and accurate information per the GLP regulations.
Ensure that research participants and QAU have access to IR-4 custom developed electronic QA reporting system (eDOCS). Provide leadership to ensure that eDOCS remains functional and a critical component in IR-4's compliance reporting processes.
Working with IR-4 Registration Manager to scheduling QAU activities with draft Analytical Summary Reports and Final Reports to EPA to ensure that IR-4's research and QAU resources are utilized efficiently and IR-4 timelines are maintained.
Represent the IR-4 Project with its GLP compliance program with the EPA's Office of Compliance and Office of Pesticide Programs as well as FDA if necessary. Continue to learn best management practices through these interactions.
As Chief Compliance Officer, lead in training of IR-4 scientists and study participants in aspects necessary to achieve compliance with EPA's GLP. Priorities for training needs are coordinated with the IR-4 National Training Committee to ensure that training is consistent throughout the United States. Participate in the planning and implementation of IR-4 National Education Conference.
Supervise IR-4 Quality Assurance Unit staff. This includes up to three direct reports at IR-4 Project Headquarters and up to six indirect reports at other Universities that host major IR-4 Project units (Michigan State University, University of Florida, University of California-Davis, etc).
Establish and communicate performance goals with QAU professionals.
Conduct performance appraisals for QAU.
Provide feedback on QAU performance to IR-4 Project Management Committee.
Initiate corrective actions when deemed appropriate.
Conduct Audits (10%):
Perform detailed and complete audits of IR-4 data, protocols and reports for assessment of compliance to the US EPA Good Laboratory Practices (GLP) regulations as necessary.
Communicate results of inspections to program participants, provide recommended corrective actions and advise IR-4 management on GLP compliance needs and recommendations for corrective actions.
Program Management and Policy Development (10%):
Participate in weekly IR-4 Headquarters Management Team decision-making efforts.
Provide direction and recommendations to Executive Director on decisions involving GLP compliance.
Attend IR-4 Project Management Committee meetings and present report on QAU.
Assist IR-4 Project Management Committee in development of policy and directions.
Willing to travel to major IR-4 meetings throughout the United States.
Perform other duties as assigned.
Require post-baccalaureate credentials or a bachelor's degree plus alternative or equivalent professional training and experience may be substituted for the advanced degree on an exceptional basis.
Recent (under three years) documented training in advanced GLP training or similar coursework by the Society of Quality Assurance, National Association of Independent Crop Consultants or other credible source. Providing educational coursework to others in advance GLP training is deemed equivalent.
Ability to maintain attention to details, prioritize and meet deadlines.
Excellent oral, written, and interpersonal skills.
PhD degree in in analytical chemistry, the plant protection sciences (Entomology, Plant Pathology, Weed Science), horticulture, or related area, with at least five years of experience in quality assurance auditing involving studies performed in accordance with US EPA or FDA GLPs regulations is acceptable.
Experience in supervising a high performing team.
Active membership in the Society of Quality Assurance and/or National Association of Independent Crop Consultants.
Required license or certification:
Valid NC driver's license or ability to obtain within 60 days of start.
Certified Quality Assurance Professional (RQAP).
Position Number: 00100337
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