Sweden Job Openings
TFS HealthScience
Quality Assurance Manager
Uppsala
December 3, 2024
The Quality Assurance (QA) Manager is responsible for ensuring excellence in GCP audit management, quality oversight, and inspection readiness while contributing to the continuous improvement of quality assurance processes. This role plays a key part in maintaining compliance with ICH GCP guidelines and fostering a quality-driven mindset across the organization.
As part of our SRS/FSP team, you will be dedicated to one sponsor, a global pharmaceutical/biotech company that is an industry leader in clinical research and innovation.
Key Responsibilities:
- Oversee the end-to-end GCP audit process, including planning, execution, and reporting, to ensure compliance and continuous improvement.
- Assess and approve GCP deviations, CAPAs, and contribute to developing GCP audit strategies and annual plans.
- Act as QA representative during GCP inspections and contribute to the Inspection Readiness framework.
- Prepare reports on audits, deviations, CAPA trends, and agreed metrics to ensure quality oversight and alignment with organizational objectives.
- Collaborate with cross-functional teams to ensure compliance with Gx P requirements, vendor qualifications, and quality agreements.
- Author and review QA-related SOPs and provide guidance on clinical processes to align with regulatory and organizational standards.
- University degree in Life Sciences or related disciplines.
- Experience in Clinical Quality Assurance or clinical trial operations within the pharmaceutical industry.
- Strong knowledge of ICH GCP guidelines, regulatory requirements, and quality assurance principles.
- Documented experience in QA systems and auditing preferred.
- Proactive and detail-oriented with excellent interpersonal and multitasking skills.
- Resilience under pressure and a collaborative mindset to foster quality-focused solutions.
We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients.
A Bit More About Us
Our journey began over 27 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.
Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light, serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration. Together we make a difference.
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