Manager QA, External Audit

Job Overview: - Manages and ensures proper execution of the audit and inspection programs. Summary of Responsibilities: - Oversees and leads execution of client audit, for-cause audit and regulatory inspection end to end activities - Ensure the consistent implementation, use and review of SOPs. - Escalate issues to management in a timely manner implementing appropriate solutions, including preventative actions. - Negotiate with functional and operational internal stakeholders to improve quality and increase efficiencies. - Analyze and interpret data to lead functional process improvement initiatives to drive efficiencies and effectiveness of Regulatory Compliance and Quality Assurance (RC and QA) processes. - Lead and effectively manage constructive crucial interactions with clients or regulatory agencies. - Lead functional process improvement initiatives to drive efficiencies and effectiveness of Regulatory Compliance and Quality Assurance (RC and QA) processes. - Interpret applicable quality regulations/standards and create appropriate policies and procedures. - Ensure Regulatory Compliance and Quality Assurance (RC and QA) management responsibilities, as indicated in applicable controlled documents, are followed. - Conduct internal audits as directed, such as process/system and service provider quality assessment for qualification/requalification - All other duties as needed or assigned. Qualifications (Minimum Required): - A minimum of a bachelor’s degree in Life Sciences preferred (or equivalent Life Science experience). - Fortrea may consider relevant and equivalent experience in lieu of educational requirements. - Experience may be substituted for education. Experience (Minimum Required): - 10+ years of experience in regulatory environment (experience in GXP roles). - Experience and regulatory expertise of industry quality systems/standards. - Ability to interpret applicable regulations/standards. - Experience in leading process improvement initiatives. - Ability to communicate and negotiate with internal stakeholders effectively. Physical Demands/Work Environment: - Some overtime and weekend work may be required. - Travel Required. Learn more about our EEO & Accommodations request here.