Director, Quality Management & Compliance

Company DescriptionErgomed Group is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease. Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia. Our company allows for employee visibility (you have a voice!) creative contribution and realistic career development. We have nourished a true international culture here at Ergomed. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved. Come and join us in this exciting journey to make a positive impact in patient’s lives. Job DescriptionProvides leadership and management of the QA team and business partners responsible for overseeing Quality Management System activitiesProvides input into the internal global audit program identifying risks and determining the number and types of audits to be conducted each year.Oversees and supports the scheduling, conduct and reporting of audits and reviews of activities in area of expertise, e.g. IT/Technology platforms, computer system validation, (technical) vendors, data management activities.Provides oversight of the escalated Issues Management program, including the review, approval, tracking, and closure of escalated Quality Issues (QIs), CAPAs, and Deviations.Mentors a team of quality professionals and makes sure that quality deliverables are provided on-time, in compliance with Ergomed standards, regulatory requirements and client expectations.Develops and drives continuous process improvements, leading, managing and directing specific assigned projectsLead training activities and contribute to policy making decisions as a resource in area of expertiseActs as the key contact and leads the preparation and hosting of sponsor audits specific to area of expertiseProvides guidance and oversight for the analysis of Root Cause and CAPA plans for quality issues (QIs) and audit findings related to relevant area of expertise.Provide input and guidance on the interpretation of regulatory requirements, GxP and clinical research related activity guidelines e.g. GAMP5Participate in system risk assessments and implementation activities for e.g. IT systems.Writes and reviews Quality Assurance departmental controlled documents and reviews other CRO department controlled documents for GCP complianceQualificationsDegree qualified in a Life Science related subjectDemonstrated experience working in a CRO environment with a focus of GCP QualityRisk-Based Quality Experience – Proven success anticipating industry trends and regulatory requirements to manage business risk, compliance, and sustainabilityIn depth knowledge of the drug development process and worldwide regulatory requirementsExcellent communication, management and collaboration skillsDemonstrated ability to lead cross-functional teamsAbility to handle multiple tasks to meet deadlines in a dynamic environmentEffective organizational, presentation, documentation and interpersonal skillsEffective problem solving and decision makingStrong customer focusAdditional InformationWe offer: Training and career development opportunities internally Strong emphasis on personal and professional growth Friendly, supportive working environment Opportunity to work with colleagues based all over the world, with English as the company language Our core values are key to how we operate, and if you feel they resonate with you then Ergomed is a great company to join! Quality Integrity & Trust Drive & Passion Agility & Responsiveness Belonging Collaborative Partnerships We look forward to welcoming your application.

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