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[QA/QC Manager] QA Compliance / Regulatory Manager

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The Regulatory/Compliance QA Manager reports to the Director, Environmental, Safety, Health & Quality (ESH&Q) with a dotted line to the TAT project team. This position is responsible for management of the Quality Assurance and Quality Control activities of TerraPower’s Targeted Alpha Therapy program. The ideal candidate will be an NQA-1 Certified Lead Auditor (or other industry recognized lead auditor certification) have management experience in a regulated environment such as NRC, FDA, FAA, etc.; and have experience with direct management of QA and QC professionals.

Key Competencies and Responsibilities
• Maintain the Pharmaceutical Quality System Manual to current FDA / ICH and/or cGMP standards
• Representative of the TAT Quality System to customers and regulatory authorities
• Develop Requirements Matrix for TAT program
• Keep Senior Management informed of the status of the Quality System
• Manage CAPA, Continuous Improvement and Risk Management processes associated with the TAT program
• Manage internal and external (supplier) audits
• Manage QC inspections
• Manage source surveillance/source verification
• Mentor/train prospective lead auditors and QC inspection personnel
• Provide direct management and development of TAT project quality assurance and quality control related staff
• Develop or review quality assurance and quality control procedures
• Review other TAT quality affecting procedures (engineering, procurement, document control, records, testing)
• Review procurement specifications, purchase orders, task orders and agreements for quality assurance and quality control requirements
• Review design specifications, test specifications/plans/procedures, and other technical documents for quality assurance requirements using a graded approach to quality
• Manage condition reports/corrective action requests associated with the TAT program

Qualifications
• Undergraduate degree or equivalent experience in a technical discipline, business, management, or quality assurance field.
• 10+ year’s experience in a quality assurance/quality control role in a regulated environment (FDA, NRC, DOE, etc.) with cGMP and FDA requirements experience
• Current certification as NQA-1 Lead Auditor or other industry recognized certification or the ability to be certified within one year of hire
• Experience successfully managing and leading a team of technical professionals
• Military experience is a plus
• The successful candidate will possess a high degree of trust and integrity, communicate openly and display respect and a desire to foster teamwork.


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