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Open nowPosted yesterday

Manager QA, External Audit

Fortrea302 open roles

Where
Bangalore
Work mode
Hybrid
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Your applicationOpen nowManager QA, External AuditFortrea · Bangalore
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The clock on this job

Early applications get read.

13.9% of postings close within 7 days. Measured by our own scanner across the market. Fortrea postings stay open a median of 18 days.

Share of postings closed within
  1. 2.2%1 day
  2. 4.7%3 days
  3. 13.9%7 days
  4. 22.4%14 days
  5. 38.1%30 days
  6. 59.0%60 days
This job: posted yesterday

Fortrea median: 18 days open

The posting

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.

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