Associate Director Quality Management

IQVIA; Deutschland; À distance; EUR 120 000 - 180 000; Plein temps

Résumé du poste

IQVIA in Munich, Germany, seeks an Associate Director of Quality Management to lead a regional clinical compliance team and drive high-quality risk-based activities across countries. You will build capability, guide regulatory interpretation, and ensure consistent application of standards.

The role combines people leadership with strategic oversight of inspections, audits, CAPA, and cross-functional partnerships with Global Clinical Compliance and QA to deliver excellent compliance and

Qualifications

• Bachelor’s degree in a scientific, medical or healthcare discipline with 8+ years in clinical operations and 6+ years in a GCP/compliance role.
• Oncology global trials experience preferred.
• Deep knowledge of ICH, GCP, SOPs and regulatory requirements.
• Strong leadership, communication and stakeholder management abilities.
• Ability to travel within the region.

Responsabilités

• Lead a regional clinical compliance team across multiple countries.
• Provide guidance on GCP and internal standards to ensure compliant practices.
• Oversee inspections, audits and CAPA processes and share lessons learned.
• Drive cross-functional alignment with Global Clinical Compliance and QA.

Connaissances

GCP knowledge

Analytical skills

Communication skills

Organizational skills

Stakeholder management

Problem solving

Team leadership

Travel ability

Fluent English

Formation

Bachelor's or higher in scientific/medical field

8+ years in clinical operations

6+ years in GCP/compliance

People management experience ≥4 years

Outils

Microsoft Office

Description du poste

Associate Director Quality Management### Associate Director Quality ManagementApply: Munich, Bavaria, Germany: Mexico City, Mexico: Chennai, India: Quebec, Canada: Basel, Switzerland: Full time: Posted Today: R1575806**General Description:** The Regional Clinical Compliance Lead is responsible for leading, developing, and managing a team of Clinical Compliance professionals supporting country- and site-level oversight. This role combines people leadership with operational and strategic accountability to ensure consistent, high-quality execution of risk-based compliance activities. This role plays a critical role in building team capability, driving performance, and ensuring alignment with global compliance strategies while fostering a culture of quality, accountability, and continuous improvement. **Essential Functions** • Serve as the primary point of contact for the RCC country compliance managers team regarding: - GCP requirements - Company and study-specific procedures - General compliance-related queries • Provide expert guidance and interpretation of regulations and internal standards to ensure consistent and compliant practices. • Oversee preparation, execution, and follow-up activities for inspections • Provide leadership support during high-impact audits and inspections. • Ensure consistent application of lessons learned across the team. *Operational Oversight & Execution Excellence* • Ensure consistent and high-quality execution of risk-based compliance activities across countries and studies. • Monitor key performance indicators (KPIs), quality metrics, and compliance trends across the team• Identify systemic risks, recurring issues, and areas for improvement. • Ensure timely escalation to Head RCC EMEA and effective resolution of critical compliance issues.• Drive accountability for CAPA quality and effectiveness. • Provide oversight and quality review of: - Remote Compliance Activities - Risk identification and mitigation strategies - Site-level compliance assessments - Drive standardization and harmonization of processes across the team. *Resource & Capacity Management* • Manage and oversee the budget, resource allocation and workload balancing across the team based on study portfolio and risk profile. • Ensure appropriate resourcing for high-risk studies, sites, and compliance activities. • Partner with senior leadership on workforce planning and capability needs. *Strategic Alignment & Cross-Functional Partnership* • Translate global compliance strategies into clear team-level objectives and actions. • Ensure alignment between local execution and global expectations by partnering with: - RCC Inspection and Audit Lead - RCC Process Excellence and Risk Surveillance - Global Clinical Compliance - Clinical Operations leadership - Quality Assurance teams • Represent the function in governance forums and cross-functional discussions. *Core Competencies, Knowledge and Skill Requirements:* • Understanding of clinical trial processes with a thorough knowledge of ICH-GCP and associated regulatory guidelines • Analytical and problem-solving skills • High attention to detail and quality orientation • Excellent communication and stakeholder management skills *Communication & Interpersonal Skills:* • Excellent English written and verbal communication and interpersonal skills • Excellent organizational skills and ability to prioritize and multi-task • Ability to work independently in multi-cultural setting and effectively handle multiple priorities in a fast-paced environment *Supervisory Responsibilities:* • Lead, coach, and develop a team of Regional Clinical Compliance professionals across multiple countries. • Set clear performance expectations and conduct regular performance reviews (goal setting, mid-year, year-end). • Build organizational capability by identifying skill gaps and implementing targeted development plans. • Foster a culture of quality, accountability, continuous improvement, and psychological safety. • Drive talent management, including succession planning and retention of key talent. • Promote an inclusive, collaborative, and high-performing team environment aligned with company values. • Encourage feedback, innovation, and continuous learning. • Model ethical behavior and reinforce a compliance mindset across the team **Qualifications**•Bachelor’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) **including people management experience (minimum 4 years).** • Experience in oncology global trials is preferred. • Requires deep knowledge of one or more related job areas typically obtained through advanced education combined with experience. • Sound working knowledge of relevant terminology, International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), applicable regulatory requirements, quality management processes. • Excellent organizational, interpersonal and communication skills. • Excellent judgement and decision-making skills. • Demonstrated leadership and line management skills. • Excellent influencing and negotiation skills. • Strong computer skills including Microsoft Office applications. • Excellent problem-solving skills. • Demonstrated ability to work in a matrix environment. • Ability to lead and motivate a clinical team also required. • Ability to travel within the region/country. • Ability to establish and maintain effective working relationships with co-workers, managers and clients. • Fluent in English.**Please note: this role is not eligible for UK VISA sponsorship.**IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com