The Lead Investigator is responsible for executing and managing product complaint investigations and trend analysis activities across commercial products, with a focus on high-risk or high-impact systems. This role ensures timely resolution of quality issues and contributes to the continuous improvement of manufacturing and quality processes.

The ideal candidate brings strong technical, analytical, and leadership capabilities to drive root cause investigations, corrective/preventive actions (CAPAs), and quality system improvements in a regulated environment.

Key Responsibilities

Complaint Handling & Investigations

• Independently lead end-to-end complaint investigations, including critical cases.
• Develop investigation plans, lead root cause analyses, and ensure timely and compliant documentation.
• Manage and approve complaint records and related CAPAs.
• Coordinate complaint resolution efforts with cross-functional and global teams.
• Serve as the quality representative during audits and inspections.

Cross-Functional Collaboration

• Partner with internal stakeholders (manufacturing, packaging, QA, regulatory, etc.) to execute robust investigations.
• Lead or contribute to cross-functional improvement initiatives.
• Mentor and train team members on complaint handling and quality investigation processes.

Quality Systems & Data Analysis

• Perform trend analysis on complaint data to identify potential product or process issues.
• Create and monitor risk metrics to enable early detection of recurring failure modes.
• Provide data to support potential recalls or regulatory reporting activities.

Process Improvement

• Identify opportunities for process optimization within complaint and quality systems.
• Drive implementation of best practices and procedural enhancements.
• Support broader quality operations as needed based on business priorities.

Qualifications

Education & Experience

• Bachelor's degree or higher in Life Sciences or a related discipline.
• 8+ years of experience in the pharmaceutical, biotech, or medical device industry.
• Proven experience in complaint handling, CAPA, and technical writing.

Technical Skills

• Deep knowledge of drug manufacturing processes and associated quality systems.
• Familiarity with combination products and medical devices is a plus.
• Proficient in quality tools (e.g., Six Sigma, DMAIC) and statistical analysis methods.
• Experience working with enterprise quality databases and reporting tools.

Competencies

• Strong knowledge of GMP and global health authority regulations.
• Excellent written and verbal communication skills.
• Demonstrated ability to lead without authority and drive collaboration across functions.
• Agile, quality-focused mindset with an emphasis on continuous improvement.
• Multilingual capabilities are an advantage but not required.