Associate Director Quality

2 months ago

Kaunas, Kaunas, Lietuva IQVIA Visą darbo dieną

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 beha

Kandidatuoti

Associate Director Quality

Panašūs darbai mieste Kaunas

Panašūs pasiūlymai

Amerika

Europa

Azija / Okeanija

Afrika

Associate Director Quality

Panašūs darbai mieste Kaunas

Panašūs pasiūlymai