About the Company
A global biotechnology organization dedicated to developing and manufacturing innovative therapies for patients with serious illnesses. Operating within a highly regulated GMP environment, the company combines scientific innovation, quality excellence, and patient focus to deliver life-changing medicines worldwide.
Role Description
As Sr. Associate QA Complaints, you will be responsible for managing and coordinating product quality complaint investigations for commercial and clinical products within a global biotech environment. You will oversee complaint records from initiation through closure, ensuring investigations are completed accurately, compliantly, and within established timelines. In this role, you will collaborate closely with internal quality teams, manufacturing sites, and external suppliers to resolve quality issues, support regulatory inspections and audits, and contribute to continuous improvement of complaint handling processes and systems.
Key Responsibilities
- Initiate and manage product quality complaint investigations for commercial and clinical products
- Perform complaint assessments in accordance with internal procedures and regulatory guidelines
- Ensure investigations are completed accurately, compliantly, and within timelines
- Collaborate with internal teams, manufacturing sites, and external suppliers to resolve complaints
- Escalate potential quality and compliance risks to management when required
- Support regulatory inspections and internal/external audits related to complaint handling
- Maintain accurate complaint documentation and data within quality systems
- Contribute to continuous improvement initiatives related to complaint processes and systems
- Support cross-functional communication regarding investigation progress and outcomes
- Ensure adherence to GMP and quality standards at all times
Requirements
- Bachelor’s or Master’s degree, preferably in a scientific discipline
- Experience within Quality Assurance, complaints handling, or manufacturing in biotech or pharmaceutical industry
- Understanding of GMP-regulated environments and quality systems
- Knowledge of manufacturing and testing processes such as API, Drug Substance, Drug Product, Packaging, or Device manufacturing
- Strong organizational skills with the ability to manage multiple investigations simultaneously
- Experience with project management tools is a plus
- High attention to detail and strong documentation skills
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About us
Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.
SIRE Life Sciences is proud of its ability to adapt to changing trends while always maintaining the highest level of quality for both our clients and our candidates.
Our team of knowledgeable professionals provides customized staffing services to clients and candidates, including secondment, direct hire, temporary-to-hire, temporary staffing, brokering, Statement of Work and we approach each type with the same degree of professional assessment. Our refined and collaborative style is unmatched in the staffing industry. We’re able to see beyond the surface to create matches that result in successful careers for our candidates and valuable talent for our clients.
Effective employment solutions need to put the right person in the relevant place every time, using advanced systems to streamline costs and time-frames for clients.