Quality Assurance Manager
Quality Assurance Manager
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Salary Not Disclosed
1 Vacancy
Job Description
TFS HealthScience is a leading global midsize Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes fullservice capabilities resourcing and Functional Service (FSP) solutions.
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 qualitydriven 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 endtoend 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 crossfunctional teams to ensure compliance with GxP requirements vendor qualifications and quality agreements.
- Author and review QArelated SOPs and provide guidance on clinical processes to align with regulatory and organizational standards.
Qualifications:
- 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 detailoriented with excellent interpersonal and multitasking skills.
- Resilience under pressure and a collaborative mindset to foster qualityfocused solutions.
What We Offer
We provide a competitive compensation package comprehensive benefits and the opportunity for personal and professional growth in a rewarding environment. Youll 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 fullservice global Contract Research Organization (CRO) we build solutiondriven 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 decisionmaking 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.
Employment Type
Full Time
