Principal Quality Assurance Strategist
hace 2 semanas
TFS HealthScience is a leading Contract Research Organization (CRO) partnering with biotech and pharmaceutical companies in clinical development. Our expertise includes full-service capabilities, resourcing, and Functional Service (FSP) solutions.
We seek a Quality Assurance Manager to support quality issue management and corrective/preventative actions (CAPA), ensuring compliance and driving process improvements across the organization.
As part of our SRS/FSP team, you will work closely with a global pharmaceutical/biotech leader advancing healthcare solutions.
Key Responsibilities:
- Maintain and approve quality issues and CAPAs in the electronic Quality Management System.
- Support internal customers with records in quality issues and root cause/CAPA processes.
- Contribute to eQMS improvements, ensuring 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.
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 English speaker with excellent communication, problem-solving, and organizational skills.
- High learning agility, self-motivated, and team-oriented with intercultural awareness.
We Offer: A competitive compensation package ($95,000 - $110,000 per year), comprehensive benefits, and opportunities for personal and professional growth in a rewarding environment. You will be part of a supportive and collaborative team working towards a healthier future.
TFS HealthScience was founded over 27 years ago in Lund, Sweden, and has grown into a global Contract Research Organization. With more than 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 a healthier future.
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