Manage global audit programs for compliance, conduct GCP and GVP audits, lead process improvement initiatives, and ensure adherence to regulations.
Job Overview:
Manages and ensures proper execution of the audit and inspection programs.
Summary of Responsibilities:
- Oversees designated global audit programs for compliance with the master audit plan, (procedures, execution, QC, compliance to process, etc.)
- Identifies the scope and leads global audits and associated audit team.
- Facilitates prioritization of global projects for risk-based audits.
- 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.
- 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).
- Experience may be substituted for education.
Experience (Minimum Required):
- 10+ years of experience in regulatory environment (experience in GXP roles).
- Experience in conducting GCP and GVP audits.
- 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.
Preferred Qualifications Include:
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Physical Demands/Work Environment:
- Some overtime required.
- Travel may be required.
- Office-Based (Hybrid), as requested by the line manager.
Learn more about our EEO & Accommodations request here.
Top Skills
GCP
Gvp
Gxp
Quality Systems
Regulatory Compliance
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