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.
