TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey.
Our expertise includes full-service capabilities, resourcing, and Functional Service (FSP) solutions.
The Quality Assurance Manager will support quality issue management and corrective and preventive actions (CAPA) management, ensuring compliance and driving continuous improvement across processes.
As part of our SRS/FSP team, you will be dedicated to a global pharmaceutical/biotech company that is an industry leader in advancing healthcare solutions.
Key Responsibilities 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.
Participate in health authority inspections.
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.
What We Offer We provide a competitive compensation package, comprehensive benefits, and opportunities for personal and professional growth in a rewarding environment.
Join our team to make a meaningful impact on patients' lives, working with a supportive and collaborative team.
A Bit More About Us Founded over 27 years ago in Lund, Sweden, TFS HealthScience is 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 us towards a healthier future.