Senior Manager

2 weeks ago

Mumbai, Maharashtra, India beBeeCompliance Full time ₹ 80,00,000 - ₹ 1,50,00,000
API Cluster Support Leadership Opportunity

This is a challenging leadership role that involves ensuring compliance with regulatory requirements across API manufacturing sites. The ideal candidate will have experience in quality management and be able to drive continuous improvement initiatives.

Main Responsibilities:
  • Compliance and Quality Oversight: Ensure compliance with cGMPs, GLPs, and regulatory requirements across API sites.
  • QMS Extension Optimization: Monitor and track QMS performance to optimize extension.
  • Quality Management Reviews: Participate in site and corporate QMRs.
  • Global Standards & Harmonization: Align site procedures with global quality standards and corporate policies.
  • Continuous Improvement Initiatives: Lead initiatives to enhance compliance, efficiency, and cost-effectiveness.
  • Regulatory Audit Support: Support internal and external audits, including remediation plan execution.
  • Metric Monitoring & Reporting: Track QA/QC metrics and ensure timely action on deviations.
  • Gaps Analysis & Process Improvements: Conduct gap analyses and implement strategies to close gaps and improve system performance.
  • Industry Trend Monitoring: Stay updated on regulatory changes and industry trends to identify improvement opportunities.
  • Site Coordination for Global Action Implementation: Coordinate quality improvement efforts across API sites to ensure consistent implementation of global actions.

The successful candidate will be responsible for monitoring and improving quality systems, facilitating quality management reviews, and driving continuous improvement initiatives. This role requires strong leadership and communication skills, as well as the ability to work effectively in a team environment.

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