Senior Executive QMS

Description:

• Independently conduct and prepare investigation reports for Product Quality Complaints, Unplanned Deviations, OOS, OOT, and OOAL events, ensuring timely closure and regulatory compliance.

• Perform root cause analysis using appropriate tools (5-Why, Fishbone, Risk Assessment, etc.) and recommend effective corrective and preventive actions (CAPA). 

• Initiate, review, track, and verify CAPA implementation and effectiveness within established timelines. 

• Review and coordinate Change Controls related to processes, equipment, facilities, systems, materials, and documentation, including quality and regulatory impact assessments. 

• Analyze and prepare annual trend reports for Unplanned Deviations, Complaints, CAPAs, OOS, OOT, and OOAL events to identify recurring issues and drive continuous improvement. 

• Prepare Quality Metrics, Management Review reports, and periodic trend analyses for site leadership. 

• Maintain QMS records in compliance with cGMP, Data Integrity (ALCOA+), and company procedures.

• Support internal audits, customer audits, and regulatory inspections. 

• Assist in the development, review, and revision of SOPs and other quality system documents. 

• Collaborate with Manufacturing, Quality Control, Engineering, Validation, and other cross-functional teams to resolve quality issues. 

• Support inspection readiness initiatives and promote continuous improvement of Quality Management Systems.

• Ensure all activities are performed in compliance with applicable cGMP, FDA, ICH, company policies, and Health & Safety requirements. 

Additional Skills

• Strong understanding of QMS principles and compliance.
• Knowledge of GMP, cGMP, GLP, GDP, and regulatory requirements from agencies such as the U.S. Food and Drug Administration, European Medicines Agency, and World Health Organization.
• Strong attention to detail to identify documentation errors and ensure data integrity.
• Strong written and verbal communication skills for preparing reports, leading discussions, and driving quality initiatives.