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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 TerraPowers 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
Undergraduate degree or equivalent experience in a technical discipline, business, management, or quality assurance field.
10+ years 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.