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Quality Assurance and Regulatory Affairs Manager

Date: Jan 10, 2023

Location: Oak Ridge, TN, US, 37830

Company: Oak Ridge National Laboratory

Requisition Id 8815 


The Oak Ridge National Laboratory seeks to hire a Quality Assurance and Regulatory Affairs Manager. The position is in the National Isotope Development Center (NIDC), reporting to the NIDC manager. The NIDC serves as an interface with the isotope user community and coordinates isotope production across numerous program facilities (including ORNL) for the U.S. Department of Energy Isotope Program (DOE IP). The management function is responsible for development, implementation, and maintenance of an integrated quality assurance system for the DOE IP.  The position works directly with the DOE IP site headquarter managers to develop, implement, and maintain quality systems that meet regulatory, operational, and customer specifications for all stable and radioisotope products produced at the multiple sites. The approved QA systems shall encompass the product life-cycle beginning with specifications in the NIDC catalog and ending with a certified product at the time of delivery to the customer. The QA Specialist shall be responsible for providing guidance on compliance with the applicable quality assurance regulations at the DOE IP sites and shall participate in audits conducted by regulatory authorities and customers.


Major Duties/Responsibilities: 

  • Develop an overarching quality system for the DOE IP which may include compliance with ICH Q7 for facilities and equipment, manufacturing and analytical testing, facility and environmental requirements, raw materials, personnel and final product specifications.
  • Assist DOE IP sites in evaluating, designing and implementing current Good Manufacturing Practices (cGMP), such as purchasing and storage of raw materials/components, staff qualification, product stability, processing validations, operating procedures, documentation system, process controls, testing and distribution of DOE IP radiopharmaceutical ingredients.
  • Monitor and provide direction to ensure compliance with establishing systems using trending data, internal audits, and corrective and preventative action (CAPA) for compliance to ICH Q7, ASME-NQA1 and ISO 9001:2015 as they relate to the DOE IP.
  • Provide technical and administrative leadership in all aspects of quality control/quality assurance functions. This includes quality control labs, equipment, method qualification and validation, strategic planning, budgeting, and staffing.
  • Support site personnel during audits by regulatory authorities and customers.
  • Develop and maintain a DOE IP QA Plan.
  • Define content and format for the website catalog specifications, work authorizations, analytical data, and product certification for all DOE IP products and services.
  • Develop guidelines for ensuring quality and quantity verification for all isotope shipments.
  • Document all customer complaints/issues and develop associated corrective actions at all sites.
  • Document and measure performance to DOE IP metrics at all sites.


Basic Qualifications:

  • A Bachelor’s Degree in science, engineering, or related field with 8 to 12 years of quality experience or an equivalent combination of education and experience, is required.
  • The ability to obtain and maintain a DOE “Q” security clearance, which requires US Citizenship or Legal Permanent Resident (LPR) status.
  • Exceptional teamwork and statistical skills, with attention to detail and precision required.
  • Experience in radiochemistry, radiopharmacy and/or nuclear medicine is highly desirable.
  • Experience in implementing and maintaining compliance with the requirements of cGMP is desired.
  • Experience working in an FDA-regulated environment at a radiopharmaceutical facility is desired.
  • Knowledge of ICH Q7, USP, State Pharmacy Board and international drug and/or device regulations is desired.
  • Understanding and experience with implementation of change control is desirable.
  • Knowledge of maintaining a Drug Master File is desirable.
  • Knowledge of sterile product manufacturing is desired.
  • Experience with handling external audits and assessments is desired. 
  • Knowledge of NQA-1 standards is desired.
  • Experience interacting with auditors, especially the FDA and other regulatory agencies, is desired.
  • Experience working cross-functionally to interpret requirements and educating others on those requirements.
  • A demonstrated track record of investigation analysis and problem solving.
  • Extremely self-motivated, creative, and passionate with excellent written and oral communication skills and the ability to multi-task.
  • Work experience and/or training involving nationally or internationally recognized quality standards or quality-related regulations.
  • Experience with integrating various requirements into a cohesive, effective, and efficient approach.


Preferred Qualifications:

  • Lead auditor certification
  • Experience working in FDA-regulated and/or ICH Q7 quality assurance environment at a radiopharmaceutical facility


Special Requirements:

Q clearance: This position requires the ability to obtain and maintain a clearance from the Department of Energy. As such, this position is a Workplace Substance Abuse (WSAP) testing designated position. WSAP positions require passing a pre-placement drug test and participation in an ongoing random drug testing program.



Promoted:  #LI-DC1



This position will remain open for a minimum of 5 days after which it will close when a qualified candidate is identified and/or hired.

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ORNL is an equal opportunity employer. All qualified applicants, including individuals with disabilities and protected veterans, are encouraged to apply.  UT-Battelle is an E-Verify employer.

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