Senior Clinical Quality Manager

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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 Provider (FSP) solutions.

Position: Quality Manager

This is a hybrid role, with 3 days on-site per week.

Key Responsibilities:

• Provide competent advice on local regulations related to clinical trials, stay updated on changes, and ensure local teams and processes are compliant.
• Support and guide operational staff in preparing for audits and inspections, including risk analysis and developing inspection readiness strategies.
• Prepare and deliver training sessions as appropriate.
• Participate in internal meetings and liaise with other departments as necessary.
• Maintain knowledge of applicable regulations and company standards and procedures.

Qualifications:

• Bachelor's degree in a related discipline.
• At least 5 years of experience in the pharmaceutical industry, preferably in Clinical Operations or Quality Assurance.
• Good knowledge of ICH-GCP, study management, site management, and monitoring.
• Strong planning, organization, and problem-solving skills.
• Advanced proficiency in MS Office applications.
• Ability to multitask, prioritize, and complete objectives efficiently.

What We Offer:

We provide a competitive compensation package, comprehensive benefits, and opportunities for personal and professional growth in a rewarding environment. Join a team that values collaboration, innovation, and making a difference in patients' lives.

About Us:

Founded over 27 years ago in Lund, Sweden, TFS HealthScience is a full-service, global CRO with over 800 professionals. We deliver tailored clinical research services across more than 40 countries, focusing on therapeutic areas such as Dermatology, Neuroscience, Oncology, and Ophthalmology.

Our core values—Trust, Quality, Passion, Flexibility, and Sustainability—guide our decision-making and organizational culture. We strive to attract and retain talented individuals who share these values, fostering a culture of innovation, excellence, and mutual respect. Together, we make a difference.