Senior Quality Manager

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.

Join Our Team as a Senior Quality Manager - (home based in Poland or Spain)

About this role

As part of our Quality team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.

The Senior Quality Manager is responsible for for functional and project-level quality oversight within the assigned scope and for dedicated assigned quality management area.

Key Responsibilities:

• Provides functional and project-level quality oversight across assigned scope ensuring compliance with GCP and other applicable GxP regulations.

• Support and participate in eQMS lifecycle activities including validation oversight activities as required.

• Oversees and performs vendor quality management activities including qualification risk assessment and RFIs; reviews and approves outputs generated by Quality Managers

• Supports business units and clients on projects including development and maintenance of project-specific quality frameworks and procedures.

• Generates reviews and approves controlled documents; ensures consistency regulatory compliance and alignment with the QMS.

• Manages quality issues and CAPAs including oversight of investigations escalation of significant risks or delays and decision-making on critical issues and suspected serious breaches.

• Participates in quality risk management activities including risk identification assessment and review
  

Qualifications:

• Bachelors degree in Life Sciences (or equivalent experience)

• 5 years in quality management/QA;

• 5 years in GxP auditing - nice to have

• Strong expertise in GCP/GxP QMS and system validation

• Proven ability to work independently and lead complex quality activities
  

TFS is committed to equal opportunities. All our vacancies are open to people with disabilities in accordance with the General Law on the Rights of Persons with Disabilities (Royal Legislative Decree 1/2013).

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 30 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 600 professionals TFS delivers tailored clinical research services in more than 50 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.