Requisition Id 15647

Overview:

The Oak Ridge National Laboratory (ORNL) seeks to hire a Quality Assurance and Regulatory Affairs Manager. The position is in the National Isotope Development Center (NIDC), reporting to the NIDC Director. 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 position works directly with the DOE IP site headquarter managers to develop, implement, and maintain an integrated quality assurance system for the DOE IP that meets regulatory, operational, and customer specifications for all stable and radioisotope products produced at the multiple sites. The approved QA systems shall encompass the product lifecycle, beginning with specifications defined in the NIDC catalog and ending with a certified product at the time of delivery to the customer.

Major Duties/Responsibilities:

• Establish and maintain a comprehensive DOE IP quality management plan that ensures compliance with overarching regulatory requirements for all production site operations.
• Develop, revise, and maintain NIDC Standard Operating Procedures to reflect current best practices and industry standards.
• Develop a global internal audit management plan to monitor and provide direction to ensure compliance with established systems for compliance to FDA, ASME-NQA-1, ISO 9001:2015, and other relevant regulatory standards as they relate to the DOE IP function and mission.
• Provide technical and administrative leadership in all aspects of quality control/quality assurance functions. This includes quality control of labs, equipment, method qualification and validation, strategic planning, budgeting, and staffing.
• Support site personnel during audits by regulatory authorities and customers.
• Define content and format for the website catalog product information, 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.
• Act as liaison between external stakeholders, laboratories, and DOE to ensure tracking and effective closure of all customer complaints.
• Document and measure any quality-related performance to DOE IP metrics at all sites.
• Promote a culture of continuous improvement by encouraging staff to identify and implement process improvements that enhance NIDC and laboratory efficiency and compliance.
• Maintain communication with internal and external stakeholders, including regulatory agencies, to ensure compliance with all relevant guidelines and standards.
• Deliver ORNL’s mission by aligning behaviors, priorities, and interactions with our core values of Impact, Integrity, Teamwork, Safety, and Service. Promote equal opportunity by fostering a respectful workplace – in how we treat one another, work together, and measure success.

Basic Qualifications:

• A BS in science, engineering, or related field with 8 to 12 years of quality experience. An equivalent combination of education and experience may be considered.
• Experience in radiochemistry, radiopharmacy and/or nuclear medicine.
• Understanding and experience with implementation and management of change control.
• Knowledge of maintaining a Drug Master File.
• Experience with handling external audits and assessments.
• Experience interacting with auditors, especially the FDA and other regulatory agencies.
• Exceptional teamwork and statistical skills, with attention to detail and precision.
• Excellent written and oral communication skills and the ability to multi-task.
• Experience working cross-functionally to interpret requirements and educating others on those requirements.
• Experience with integrating various requirements into a cohesive, effective, and efficient approach.
• Extremely self-motivated, creative, and passionate.

Preferred Qualifications:

• Lead auditor certification.
• Work experience and/or training involving nationally or internationally recognized quality standards or quality-related regulations, including ASME-NQA-1 and ISO 9001:2015.
• A demonstrated track record of investigation analysis and root cause analysis.
• Experience working in an FDA-regulated environment at a radiopharmaceutical facility.
• Experience in implementing and maintaining compliance with the requirements of cGMP.

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.
• Visa sponsorship: Visa sponsorship is not available for this position.

Relocation:

Moving can be overwhelming and expensive. UT-Battelle offers a generous relocation package to ease the transition process. Domestic and international relocation assistance is available for certain positions. If invited to interview, be sure to ask your Recruiter (Talent Acquisition Partner) for details.

About ORNL:

As a U.S. Department of Energy (DOE) Office of Science national laboratory, ORNL has an impressive 80-year legacy of addressing the nation’s most pressing challenges. Our team is made up of over 7,000 dedicated and innovative individuals! Our goal is to create an environment where a variety of perspectives and backgrounds are valued, ensuring ORNL is known as a top choice for employment. These principles are essential for supporting our broader mission to drive scientific breakthroughs and translate them into solutions for energy, environmental, and security challenges facing the nation.

ORNL offers competitive pay and benefits programs to attract and retain individuals who demonstrate exceptional work behaviors. The laboratory provides a range of employee benefits, including medical and retirement plans and flexible work hours, to support the well-being of you and your family. Employee amenities such as on-site fitness, banking, and cafeteria facilities are also available for added convenience.

Other benefits include the following: Prescription Drug Plan, Dental Plan, Vision Plan, 401(k) Retirement Plan, Contributory Pension Plan, Life Insurance, Disability Benefits, Generous Vacation and Holidays, Parental Leave, Legal Insurance with Identity Theft Protection, Employee Assistance Plan, Flexible Spending Accounts, Health Savings Accounts, Wellness Programs, Educational Assistance, Relocation Assistance, and Employee Discounts.

If you have difficulty using the online application system or need an accommodation to apply due to a disability, please email: ORNLRecruiting@ornl.gov.

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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.

We accept Word (.doc, .docx), Adobe (unsecured .pdf), Rich Text Format (.rtf), and HTML (.htm, .html) up to 5MB in size. Resumes from third party vendors will not be accepted; these resumes will be deleted and the candidates submitted will not be considered for employment.

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.