Ensure execution of the quality complaint process in compliance with procedures, laws, and regulations.Maintain high quality in complaint records and related tasks.Lead team initiatives and projects focused on process and performance improvement.Establish clear performance expectations and drive daily improvement.Prioritize workload based on changing volumes and record flow.Lead and mentor complaint investigators, offering guidance and support.Raise potential quality issues to management promptly.Monitor and oversee team and individual staff performance and development.Ensure ongoing training and compliance with quality standards.Manage daily operations of complaint handling team.Participate in audits and assessments by providing necessary documentation and process knowledge.Foster a culture of continuous improvement and customer focus.Basic Qualifications :
- Doctorate degree
- OR
- Master's degree with 4–6 years of quality management (focus on complaint handling)
- OR
- Bachelor's degree with 6–8 years of relevant experience
- OR
- Diploma with 10–12 years of relevant experience
Preferred Qualifications :
- Quality and manufacturing experience in biotech, medical device, or pharmaceutical industry
- Strong leadership and multitasking skills across projects
- Familiarity with advanced project management tools
- Ability to work effectively in a matrixed / team environment
- Experience applying DAI (Decision, Alignment, and Integration) principles
- Knowledge of QMS requirements and manufacturing / testing processes (e.g., API, Drug Product, Packaging)
- Strategic negotiation skills and cross-functional leadership experience
- Strong rapport-building and conflict-resolution abilities
- Adaptable complaint-handling strategies based on unique scenarios
- Global collaboration and regulatory compliance navigation
- Customer-first mindset and issue resolution perspective
- Willingness to travel up to 20% domestically / internationally
Skills Required
Continuous Improvement, Quality Management, Qms, Regulatory Compliance, Team Leadership, Complaint Handling