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Quality Compliance - Senior Manager

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Amgen

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Location:
India , Hyderabad

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Contract Type:
Not provided

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Salary:

Not provided

Job Description:

Join Amgen’s Mission of Serving Patients. In this vital role you will be responsible for implementing Global Quality Compliance Audits and assigned tasks and/or projects necessary to achieve corporate and departmental goals.

Job Responsibility:

  • Coordinates, leads, or participates in Corporate Quality Compliance Audits of Corporate Quality Management System, Amgen sites, Contract facilities, Affiliates, and Critical Service providers
  • Assesses state of compliance with appropriate regulations and lead or participates in the assessment of action plans to correct deficiencies
  • Implements risk assessments
  • Ensure completion, maintenance and sustainability of the assigned training per specific roles to support the audit process
  • Provides leadership toward calling out site and multi-site compliance issues resulting from audit findings
  • Serves as subject matter expert on global regulated requirements and inspectional commitments
  • Provides support for domestic and international Regulatory Authority Inspections when necessary
  • Provides technical support/compliance review of multi-site/global documents resolving compliance issues
  • Interacts with other functional leads to ensure that Amgen Standards, strategies and direction are aligned with existing regulations and regulatory expectations
  • Alerts senior and/or executive management of significant quality, and compliance risks
  • Provides support for audit and inspection metrics as vital
  • Supports Continual Improvement initiatives, programs and projects

Requirements:

  • Master’s degree
  • 12 to 15 years in Pharmaceutical and/or Biotechnology in Quality and/or Manufacturing experience
  • Lead Auditor Certification
  • Audit Experience in Drug Substance (DS), Drug Product (DP), Finished Drug Product (FDP), Medical Device, Combination Product, and/or Active Pharmaceutical Ingredients (API)
  • Strong communication skills both verbal and written
  • Domestic and International travel up to 50%

Nice to have:

  • Lead Auditor Certification
  • Audit Experience in Drug Substance (DS), Drug Product (DP), Finished Drug Product (FDP), Medical Device, Combination Product, and/or Active Pharmaceutical Ingredients (API)
  • Strong communication skills both verbal and written
What we offer:

competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Additional Information:

Job Posted:
February 08, 2026

Employment Type:
Fulltime
Work Type:
On-site work
Job Link Share:

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