Manager, QA (IC role)
Fortrea
Date: 2 weeks ago
City: Pune, Maharashtra
Contract type: Full time
Job Overview
Manages and ensures proper execution of the audit and inspection programs.
Summary Of Responsibilities
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.
- A minimum of a bachelor’s degree in Life Sciences preferred (or equivalent Life Science experience).
- Experience may be substituted for education.
- 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.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
- Some overtime required.
- Travel may be required.
- Office-Based (Hybrid), as requested by the line manager.
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