Principal Quality Manager

Description

<p>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.</p><p><strong>Join Our Team as a</strong> <strong>Principal Quality Manager (home-based in Poland or Spain)</strong></p><p><strong>About this role</strong></p><p>As part of our <strong>Quality</strong> team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.<br><br>The <strong>Principal Quality Manager </strong>acts a<span>s a subject matter expert and escalation lead for complex quality issues, inspection readiness, and quality risk management, and ensures consistent, compliant and inspection-ready execution of quality activities across projects, vendors, and systems, while coaching and mentoring Quality Managers and supporting continuous improvement of the Quality Management System</span><em><br></em></p><p><strong>Key Responsibilities:&nbsp;</strong></p><ul><li><p><span>Maintains quality oversight for multiple projects, vendors, and/or systems, ensuring consistent and compliant execution.</span></p></li><li><p><span>Acts as escalation point for complex, high-risk or systemic quality issues, inspection risks, and compliance concerns within assigned scope.</span></p></li><li><p><span>Leads complex investigations, including suspected serious breaches, fraud and misconduct and systemic quality issues; ensures robust CAPA development, effectiveness checks, and trend analysis.</span></p></li><li><p><span>Acts as lead auditor for routine audits and leads complex audits and inspections; defines inspection response strategy, coordinates execution, and supports senior management during high‑risk or regulatory‑critical inspections. Leads inspection readiness activities.</span></p></li><li><p><span>Acts as subject matter expert for one or more QMS elements (e.g. CAPA, Audit Program, Vendor Quality Management, Inspection Readiness, Training Compliance, CSV Quality Oversight) and supports continuous improvement initiatives within those areas</span></p></li><li><p><span>Develops, reviews, and maintains controlled documents within assigned scope and ensures alignment of assigned processes, procedures, and tools with the company QMS and applicable GxP regulations.</span></p></li><li><p><span>Leads and/or performs quality risk assessments and participates in risk management reviews.</span></p></li><li><p><span>Reports KQIs, KPIs, quality metrics, trends, and improvement opportunities.</span></p></li><li><p><span>Performs audits, acts as lead auditor for complex audits and supports audit program planning and execution.</span></p></li><li><p><span>Mentors auditors and supports audit quality and consistency.</span></p></li><li><p><span>Leads vendor qualification and oversight activities, including risk assessments, RFIs, performance monitoring, and re‑qualification activities.</span></p></li></ul><p><strong>Qualifications:&nbsp;</strong></p><ul><li><p><span>Bachelor’s degree in Life Sciences or equivalent, or relevant experience in quality management and auditing.</span></p></li><li><p><span>Minimum 10 years of demonstrated experience in quality management and quality assurance processes.</span></p></li><li><p><span>Minimum 7 years’ audit experience across different types of GCP and other GxP audits; lead auditor experience preferred.</span></p></li><li><p><span>Experience working in clinical research environments (CRO and/or Sponsor).</span></p></li><li><p><span>Excellent knowledge of GxP regulations and guidance with the ability to interpret and translate requirements into pragmatic processes</span></p></li><li><p><span>Strong understanding of Quality Management Systems, quality standards, inspection requirements, and inspection response management.</span></p></li><li><p><span>Proficiency in MS Office, data analysis tools, and quality assurance software/eQMS tools.</span></p></li></ul><p><span><strong><em>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).</em></strong></span></p><p><strong>What We Offer</strong></p><p>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</p><p><strong>A Bit More About Us</strong></p><p>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.</p><p>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.&nbsp;</p><p><strong>Together we make a difference.</strong></p>