Senior Quality Specialist

Overview<br/><br/>LabConnect improves lives by partnering with pharmaceutical and biotech companies, and clinical research organizations (CROs) to accelerate the development of new medicines around the world.<br/><br/>We are an independent, global, one-stop-shop focused on delivering Central Laboratory Services that are tailor-made, timely and flexible to meet the evolving study demands of traditional to increasingly complex trials. Additionally, we provide Functional Service Provider (FSP) Solutions, supporting our clients with scientific and technical expertise, acting as an extension of their team, coordinating all laboratory related needs, advising on strategies for lab data collection and providing end-to-end analytical and logistical solutions.<br/><br/><br/>Summary<br/>Responsible for managing active and completed studies archives and maintaining QMS logs and records and assisting the Director of Quality Assurance in monitoring regulatory compliance and quality in clinical trial operational activities.<br/><br/><br/>Essential Duties and Responsibilities<br/><br/> • Contribute to the implementation, maintenance, continuous improvement, and advancement of GxP-compliant Quality Management Systems (QMS), ensuring alignment with both local and global regulatory requirements.<br/><br/> • Coordinate and host external audits and assessments at LabConnect facilities in Germany and the Netherlands, ensuring readiness and compliance with GxP and ICH-GCP standards.<br/><br/> • Support the management of clinical trial documentation, assisting the Document Retention Administrator with the archival and retrieval of ICH E6-regulated documents. Act as a liaison with clients and stakeholders to coordinate document transfers and ensure timely access to archived materials.<br/><br/> • Conduct internal audits and ensure effective follow-up and closure of corrective actions.<br/><br/> • Assist in the investigation of quality events, deviations, and non-conformances, contributing to root cause analysis (e.g., 5 Whys, Ishikawa) and implementation of corrective and preventive actions (CAPAs).<br/><br/> • Perform supplier qualification and re-evaluation activities, both onsite and remotely, using the global electronic Quality Management System (eQMS), ensuring vendor compliance with LabConnect quality standards.<br/><br/> • Review Change Control documentation, providing guidance operational teams on regulatory compliance and quality-related matters.<br/><br/> • Support software validation efforts related to clinical trial systems, ensuring validation activities meet regulatory expectations and internal quality standards.<br/><br/> • Collaborate cross-functionally with internal departments to address client quality-related requests and ensure alignment with clinical trial protocols and regulatory expectations.<br/><br/> • Perform additional quality-related tasks as assigned, contributing to the overall effectiveness of the Quality Assurance department at LabConnect.<br/><br/><br/>Education/Experience<br/><br/><br/> • 4 -year degree with at least 4 years Quality Assurance experience within the clinical trial or pharmaceutical industry or a 2-year degree with more than 7 years related experience and/or training or equivalent combination of education and experience related with Quality Assurance in the pharmaceutical or clinical research industry.<br/><br/> • Proven experience conducting internal audits, supporting regulatory inspections, and managing CAPA processes.<br/><br/> • Familiarity with document management systems and electronic Quality Management Systems (eQMS).<br/>Strong analytical and problem-solving skills, including proficiency in root cause analysis tools (e.g., 5 Whys, Ishikawa).<br/><br/> • Prior experience as an internal or external auditor in a GxP environment is desirable.<br/><br/> • Excellent communication and interpersonal skills, with the ability to collaborate across departments and with external stakeholders.<br/><br/><br/>Language Ability<br/><br/>Fluency in English; proficiency in German or Dutch is a plus.<br/><br/><br/>Reasoning Ability<br/><br/>Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.<br/><br/><br/>Computer Skills<br/><br/>To perform this job successfully, an individual should have knowledge of Microsoft Office applications, word processing software, powerpoint; spreadsheet software and basic knowledge of database structure.<br/><br/><br/>Supervisory Responsibilities<br/><br/>This position does not have any supervisory responsibilities.<br/><br/>This position requires a high level of independent work and autonomous decision making.<br/><br/><br/>Work Environment<br/><br/>The noise level in the work environment is usually moderate.<br/><br/><br/>Physical Demands<br/><br/>T