- Lead the development, implementation, and continuous improvement of the Quality Management System (QMS).
- Collaborate with cross-functional teams to integrate quality considerations throughout all stages of clinical development projects.
- Conduct and manage quality audits (internal and external) to identify and address potential issues.
- Oversee the investigation and resolution of non-conformities and implement corrective and preventive actions (CAPA) as needed.
- Develop and deliver training programs on Good Clinical Practice (GCP) and other relevant quality regulations for TFS staff.
- Participate in regulatory inspections and liaise with regulatory authorities.
- Bachelor's or Master's degree in a relevant field (e.g., Life Sciences, Quality Assurance).
- Experience in Quality Assurance within the clinical research or pharmaceutical industry.
- Proven track record of developing, implementing, and maintaining effective quality management systems.
- In-depth knowledge of GCP and other relevant quality regulations (e.g., ICH GCP).
- Excellent communication and interpersonal skills.
- Ability to work independently, manage multiple priorities, and meet deadlines.
- Strong analytical and problem-solving skills.
- Join a collaborative and supportive team dedicated to advancing healthcare.
- Work in a dynamic environment that fosters continuous learning and professional development.
- Make a real impact on the development of life-changing treatments.
- Be part of a growing and successful CRO.
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Quality Assurance Manager - Lund, Sverige - TFS HealthScience
Beskrivning
Are you passionate about ensuring the highest quality standards in clinical research? Join our dynamic team at TFS HealthScience as we partner with leading biopharmaceutical companies to develop life-changing treatments.
Sponsored role - Based in Sweden, Skåne.
About Us:
TFS HealthScience is a leading mid-sized Contract Research Organization (CRO) dedicated to excellence and innovation in clinical development. We partner with biotechnology and pharmaceutical companies to deliver high-quality solutions that make a tangible difference in patient lives.
About the Opportunity:
As Quality Assurance Manager, you'll play a critical role in developing and maintaining a robust quality system. You'll ensure adherence to rigorous standards and contribute to the success of our clients' clinical development programs.
Key Responsibilities:
Qualifications:
Why Choose TFS HealthScience?
Ready to take your quality assurance expertise to the next level? Apply today
