Quality Compliance Senior Manager

Roles & Responsibilities

• Provide leadership and mentorship to the Amgen India R&D Quality team and oversee daily operational activities
• Support the intake, triage, and categorization of deviations, ensuring accurate classification and documentation
• Facilitate timely deviation investigations with functional area representatives and Quality Leads
• Ensure consistent, compliant documentation of deviation records in DQMS
• Monitor adherence to quality timelines and escalate risks or delays when necessary
• Collaborate with Global Patient Safety and Development teams on GxP inspection and audit activities
• Offer end-to-end quality support for deviation, root cause analysis (RCA), and CAPA management
• Identify and lead continuous improvement initiatives within CAPA management
• Ensure alignment of quality processes with evolving regulations and industry standards
• Maintain data integrity, traceability, and compliance with ALCOA+ principles
• Monitor and analyze quality metrics and key performance indicators (KPIs)
• Conduct trend analysis and root cause trending to identify systemic issues
• Utilize tools such as Excel, Smartsheet, and SharePoint for data analysis and documentation
• Maintain current knowledge of regulatory and quality practices
• Manage document archival and retention processes for audit documentation

Basic Qualifications

• Master's degree
• 1012 years of experience in Pharma or Biotech R&D or commercial manufacturing Quality
• Experience in continuous improvement or change management is preferred

Additional Competencies & Skills

• Exceptional attention to detail and accuracy
• Ability to work independently in a fast-paced, global environment
• Proficiency in Smartsheet, Microsoft Office Suite, and collaboration tools like Teams and WebEx
• Strong onboarding, coaching, and team development capabilities
• Familiarity with project management methodologies
• Knowledge of GCP, GLP, and/or GPvP
• Experience working in multinational, cross-functional teams
• Excellent written and verbal communication skills
• High professionalism and interpersonal effectiveness
• Strong problem-solving and adaptability
• Collaborative, positive attitude with strong relationship-building skills
• Resilience and discretion under pressure