Senior Quality Manager

TFS HealthScience; Warszawa; Remote; PLN 306,000 - 481,000; Full time

Job summary

TFS HealthScience is actively seeking a Senior Quality Manager to lead quality oversight across projects, ensuring GCP/GxP compliance and robust QMS implementation. This home-based role can be based in Poland or Spain, reflecting our global, client-focused CRO model.

In this senior position, you will drive eQMS lifecycle activities, oversee vendor QA processes, and manage CAPAs and investigations. You will collaborate with cross-functional teams to sustain risk-based quality management and

Qualifications

• Bachelor’s 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.

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, with a particular focus on validation oversight and compliance, 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
• Interpedently conducts GCP/GxP audits of vendors, systems and clinical trials.

Skills

GCP/GxP knowledge

QMS

System validation

Quality management

CAPA management

Auditing (GxP)

Education

Bachelor's degree in Life Sciences

Tools

eQMS software

Document control systems

Job description

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, with a particular focus on validation oversight and compliance, 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

• Interpedently conducts GCP/GxP audits of vendors, systems and clinical trials.

Qualifications:

• Bachelor’s 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. You’ll 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.