We are looking for an experienced Quality Investigation professional to lead the centralized investigation function across multiple pharmaceutical manufacturing sites.
The role will be responsible for ensuring robust, scientifically sound and inspection-ready investigations across laboratory, manufacturing and quality systems, with strong exposure to USFDA and global regulatory requirements
Key Responsibilities
- Lead and manage the centralized investigation team across multiple manufacturing sites.
- Oversee OOS, OOT, stability failures, Environmental Monitoring (EM) failures, microbiological and manufacturing investigations.
- Ensure investigations are scientifically sound, unbiased, data-driven and inspection-ready.
- Act as Subject Matter Expert (SME) during regulatory and customer audits.
- Lead remediation activities related to FDA 483 observations, Warning Letters and regulatory responses.
- Drive scientifically justified Root Cause Analysis (RCA)
and effective CAPA implementation.
- Monitor and ensure CAPA effectiveness and timely closure of investigations.
- Develop and standardize investigation procedures, SOPs, templates and best practices.
- Establish investigation metrics and dashboards covering cycle time, repeat deviations, CAPA effectiveness and recurring OOS trends.
- Identify recurring quality issues and drive continuous improvement initiatives.
- Build, mentor and develop a strong investigation team.
- Partner with QA, QC, Manufacturing, Engineering and other cross-functional teams for effective investigations.
Experience
- 18-25+ years in pharmaceutical quality operations in regulated manufacturing environments.
- Minimum 10+ years handling OOS investigations, laboratory investigations, regulatory inspections, and quality systems leadership.
- Robust exposure to USFDA-regulated facilities and global regulatory inspections.