Quality Assurance Expert Leader
hace 19 horas
TFS HealthScience is a leading global Contract Research Organization (CRO) with extensive expertise in clinical development. We partner with biotechnology and pharmaceutical companies to support their entire journey, from initial stages to market approval.
Our Quality Assurance Manager role plays a crucial part in ensuring compliance and driving continuous improvement across processes within our SRS/FSP team. You will be dedicated to a global pharmaceutical/biotech company that is an industry leader in advancing healthcare solutions.
- Maintain and approve quality issues and CAPAs in the electronic Quality Management System (eQMS)
- Provide support to internal customers with records in quality issues and root cause/CAPA processes
- Contribute to improvements in the eQMS and ensure high-quality data metrics and KPIs
- Drive quality through proactive support, training, coaching, and consulting, adhering to quality by design principles
- Advise internal teams on addressing issues while ensuring compliance with global regulations and standard operating procedures
- Identify risk areas proactively, offering solutions that align with business needs
We estimate the salary for this position to be around $90,000 - $120,000 per year, depending on your experience and qualifications.
Qualifications- Extensive experience in Quality Assurance within the pharmaceutical/biotech industry or clinical development
- Proficient in managing deviations, quality issues, and CAPA processes
- Expertise in continuous improvement methodologies, including Lean Six Sigma
- In-depth knowledge of GCP regulations, ICH guidelines, and validation principles (e.g., GAMP5)
- Basic understanding of other GxP disciplines, such as GVP, GLP, GRP, and GMP
- Strong understanding of QA principles, risk management, and regulatory frameworks
- Experience with computerized system development
- Fluent in English with excellent communication, problem-solving, and organizational skills
- High learning agility, self-motivated, and team-oriented with intercultural awareness
We provide a competitive compensation package, comprehensive benefits, and opportunities for personal and professional growth in a rewarding environment.
About UsFounded over 27 years ago in Lund, Sweden, TFS HealthScience is a global Contract Research Organization with over 800 professionals across 40 countries. We offer flexible, solution-driven clinical research services in key therapeutic areas, including Dermatology, Neuroscience, Oncology, and Ophthalmology. Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide us in creating a unified, innovative, and collaborative culture, driving us towards a healthier future.
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