Senior Training and Compliance Manager

ppAs we continue to grow, we are looking for a Senior Training Compliance Manager who combines deep clinical research expertise with a hands‑on mindset. In this role, together with your colleagues in the Training and Compliance team, you will lead, support and further develop our training, compliance, and quality initiatives across the organization. /p pYou will act as a trusted advisor to Clinical Operations and project teams, helping to ensure inspection readiness, regulatory compliance, and operational excellence. At the same time, you will contribute to the strategic development of the Training Compliance department by identifying opportunities for improvement, supporting departmental initiatives, and helping shape the future of quality at CR2O. /p pThis role is ideal for someone who enjoys both operational involvement and strategic thinking. /p pAs Senior Training Compliance Manager, you will: /p ul liAdvice clinical project teams in maintaining compliance and inspection readiness /li liAct as a subject matter expert on GCP, regulatory requirements, training management and compliance management /li liPerform hands‑on compliance activities to support the maintenance of our QMS /li liLead and support training initiatives that strengthen knowledge, competence, and quality awareness /li liServe as a strategic sparring partner to the Director Quality Assurance, Training Compliance /li liContribute to the continuous improvement and future development of the Training Compliance department /li /ul h3Key Responsibilities /h3 h3Training /h3 ul liCreate and maintain role specific training programs /li liIdentify training needs to ensure operational excellence company wide /li liSupport trainers to develop and improve training materials /li liEnsure training requirements remain aligned with procedural and regulatory changes /li liSupport employees and line managers in maintaining inspection‑ready personnel training files /li liMonitor training compliance /li liLead the further development of CR2O's training framework and learning culture /li liAuthor Training SOPs /li /ul h3Quality Management System /h3 ul liLead the ongoing maintenance and development of procedural documents (SOP/WI/templates) /li liEnsure the procedural documents remain aligned with regulatory changes and industry trends /li /ul h3Compliance /h3 ul liCreate and execute the annual compliance program /li liPerform compliance reviews and identify risks, gaps, and improvement opportunities /li liMonitor and help resolve compliance issues in collaboration with project teams /li liPartner with Quality Assurance and operational teams to strengthen risk‑based quality management /li liAuthor Compliance SOPs /li liSupport the Director Quality Assurance, Training Compliance in shaping departmental priorities and initiatives /li liLead or contribute to cross‑functional improvement projects /li liAct as a mentor and role model for colleagues /li liPromote a culture of accountability, collaboration, learning, and continuous improvement /li liActively contribute to the growth and maturity of CR2O's quality culture /li /ul h3Qualifications /h3 ul liBSc, MSc or equivalent degree in Life Sciences or a related field /li liAt least 7 years of experience in clinical research within a CRO, pharmaceutical, or biotechnology environment, including significant experience in Training and/or Compliance /li liStrong knowledge of ICH E6 (R3), CTR, GDPR and other applicable guidelines and regulations /li liExperience with training programs, compliance reviews oversight, quality management systems, and inspection readiness /li liStrong analytical and communication skills /li liAbility to work independently and drive initiatives to completion /li liFluent in English. Dutch is considered an advantage /li liExperience with the implementation of an eQMS is a plus /li /ul h3What We Offer /h3 ul liA strategic and operational combined role with direct impact on the organization /li liClose collaboration with leadership /li liOpportunity to shape and strengthen the quality culture /li liCompetitive salary and attractive benefits package /li liFlexible and hybrid working environment /li /ul /p #J-18808-Ljbffr