We are seeking a Senior Associate Quality Complaints professional to own and implement the end-to-end global complaint process and management system. This is a vital role that ensures our complaint processes and systems remain compliant with current internal and external requirements. The ideal candidate will be skilled in conducting low to medium complexity complaint investigations and will be a key player in translating market information to drive continuous improvement.
Roles & Responsibilities
- Complaint Management: Evaluate and ensure triaged product complaint records align with applicable procedures. You will own complaint records with basic investigations and ensure their quality.
- Compliance & Documentation: Implement the complaint process per SOP requirements. You will own or manage the review/approval process flow of controlled documents in CDOCS, ensuring accuracy and consistency according to templates.
- Investigation & Analysis: Apply analytical skills to evaluate complex situations using multiple sources of information. You will also determine if investigations require further action.
- Project Support: Support the management of assigned projects or project tasks, including proactive communication, status updates, and tool maintenance, to achieve results within established timelines and quality standards.
Technical Skills
- Experience in a quality and/or manufacturing role within the biotech, medical device, or pharmaceutical industry is preferred.
- Understanding of quality and industry requirements/expectations for a Quality Management System (QMS).
- Understanding of applicable manufacturing/testing processes (e.g., API, Drug Substance, Drug Product, Packaging).
- Familiarity with basic project management tools.
Qualifications
- A Master's degree with experience, a Bachelor's degree with relevant experience, or a Diploma with a substantial background in a science field or a related area of study.
Soft Skills
- Problem-Solving: Strong analytical skills with the ability to evaluate complex situations and make data-driven decisions.
- Communication: Proven ability to communicate clearly and effectively, translating business and stakeholder feedback into accurate and efficient processes.
- Collaboration: The ability to operate in a matrixed or team environment, negotiating a position after taking feedback from multiple sources.
- Ownership: A demonstrated ability to lead functional teams, consistently deliver high-quality results, and manage your workload to meet timelines.
- Proactiveness: A high degree of initiative, with the ability to manage your workload effectively and proactively communicate with stakeholders.
