Associate Director Quality Management

h3General Description: /h3 pThe Regional Clinical Compliance Lead is responsible for leading, developing, and managing a team of Clinicalbr/Compliance professionals supporting country
- and site-level oversight. This role combines people leadership withbr/operational and strategic accountability to ensure consistent, high-quality execution of risk-based compliancebr/activities.br/This role plays a critical role in building team capability, driving performance, and ensuring alignment with globalbr/compliance strategies while fostering a culture of quality, accountability, and continuous improvement. /p h3Essential Functions /h3 ul liServe as the primary point of contact for the RCC country compliance managers team regarding: br/
- GCP requirementsbr/
- Company and study-specific proceduresbr/
- General compliance-related queries /li liProvide expert guidance and interpretation of regulations and internal standards to ensure consistent and compliant practices. /li liOversee preparation, execution, and follow-up activities for inspections /li liProvide leadership support during high-impact audits and inspections. /li liEnsure consistent application of lessons learned across the team. /li /ul h3Operational Oversight Execution Excellence /h3 ul liEnsure consistent and high-quality execution of risk-based compliance activities across countries and studies. /li liMonitor key performance indicators (KPIs), quality metrics, and compliance trends across the team. /li liIdentify systemic risks, recurring issues, and areas for improvement. /li liEnsure timely escalation to Head RCC EMEA and effective resolution of critical compliance issues. /li liDrive accountability for CAPA quality and effectiveness. /li liProvide oversight and quality review of: ul liRemote Compliance Activities /li liRisk identification and mitigation strategies /li liSite-level compliance assessments /li liDrive standardization and harmonization of processes across the team. /li /ul /li /ul h3Resource Capacity Management /h3 ul liManage and oversee the budget, resource allocation and workload balancing across the team based onbr/study portfolio and risk profile. /li liEnsure appropriate resourcing for high-risk studies, sites, and compliance activities. /li liPartner with senior leadership on workforce planning and capability needs. /li /ul h3Strategic Alignment Cross-Functional Partnership /h3 ul liTranslate global compliance strategies into clear team-level objectives and actions. /li liEnsure alignment between local execution and global expectations by partnering with: ul liRCC Inspection and Audit Lead /li liRCC Process Excellence and Risk Surveillance /li liGlobal Clinical Compliance /li liClinical Operations leadership /li liQuality Assurance teams /li /ul /li liRepresent the function in governance forums and cross-functional discussions. /li /ul h3Core Competencies, Knowledge and Skill

Requirements:
/h3 ul liUnderstanding of clinical trial processes with a thorough knowledge of ICH-GCP and associatedbr/regulatory guidelines /li liAnalytical and problem-solving skills /li liHigh attention to detail and quality orientation /li liExcellent communication and stakeholder management skills /li /ul h3Communication Interpersonal

Skills:
/h3 ul liExcellent English written and verbal communication and interpersonal skills /li liExcellent organizational skills and ability to prioritize and multi-task /li liAbility to work independently in multi-cultural setting and effectively handle multiple priorities in a fast-paced environment /li /ul h3Supervisory

Responsibilities:
/h3 ul liLead, coach, and develop a team of Regional Clinical Compliance professionals across multiple countries. /li liSet clear performance expectations and conduct regular performance reviews (goal setting, mid-year, year-end). /li liBuild organizational capability by identifying skill gaps and implementing targeted development plans. /li liFoster a culture of quality, accountability, continuous improvement and psychological safety. /li liDrive talent management, including succession planning and retention of key talent. /li liPromote an inclusive, collaborative, and high-performing team environment aligned with company values. /li liEncourage feedback, innovation, and continuous learning. /li liModel ethical behavior and reinforce a compliance mindset across the team /li /ul h3Qualifications /h3 ul liBachelor’s degree (BS/BA or equivalent) or higher in a scientific, medical or healthcare discipline
* with minimum of 8 years of progressive experience in clinical operations roles plus minimum 6 years’ experience in a GCP compliance or equivalent role (i.e. quality) bincluding people management experience (minimum 4 years). /b /li liExperience in oncology global trials is preferred. /li liRequires deep knowledge of one or more related job areas typically obtained through advanced education combined with experience. /li liSound working knowledge of relevant terminology, Inte