Senior Associate, Quality Complaints

• Own and implement the end-to-end global complaint process and management system
• Ensure complaint processes and systems remain fully compliant through the quality operating standards and procedures
• Translate information from the market to drive continuous improvement
• Conduct low to medium complexity complaint investigations
• Determine if complaint investigations require issue for further investigation
• Evaluate and ensure triaged product complaint records align with applicable procedures
• Evaluate and own complaint records with basic investigations
• Ensure quality of complaint records
• Complete assigned assessments per applicable procedures
• Apply analytical skills to evaluate sophisticated situations using multiple sources of information
• Implement the complaint process per SOP requirements
• Own or manage the review/approval process flow in CDOCS of controlled documents
• Support management of assigned projects or project tasks to achieve agreed results within time and with encouraged quality
• Be willing to work in shift that overlaps with EU and US time zone, if required

• Master’s degree and 4 to 7 years of Quality experience
• Bachelor’s degree and 5 to 9 years of Quality experience
• Quality and/or manufacturing experience in biotech, medical device or pharmaceutical industry
• Bachelor’s Degree in a Science Field
• Ability to successfully manage workload to timelines
• Familiarity with basic project management tools
• Ability to operate in a matrixed or team environment with site, functional, and senior management leadership
• Experience in driving decision making by using the DAI principles
• Understanding of quality and industry requirements/expectations of a QMS
• Understanding of the applicable manufacturing/testing processes (i.e., API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
• Ability to negotiate a position after taking feedback from multiple sources
• Demonstrated ability to lead functional teams, consistently deliver timely, and high-quality results
• Ability to translate business and key collaborator feedback and requirements into accurate and efficient processes using clear language and format

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards