Auditor Automoción

Dekra España; Madrid; Presencial; EUR 65.000 - 90.000; Jornada completa

Descripción de la vacante

IQVIA is seeking a Sr. Quality Auditor to lead CAPA management across multiple sites, ensuring strong root cause analysis, effective corrective actions, and robust regulatory compliance. You will oversee audits, provide expert guidance, and drive continuous quality improvements within the CAPA framework.

The role requires extensive GCP knowledge, prior QA audit experience, and proven leadership in fast-paced environments. Travel across Europe may be required as part of audits and inspections.

Formación

• Extensive knowledge of CAPA Management, GCP guidelines and relevant regulations for clinical trials.
• 7 years Quality Assurance experience in pharmaceutical, technical, or related area with focus on GCP.
• Experience in audit and inspection management/support.
• Ability to lead and mentor CAPA teams.
• Strong root cause analysis and problem solving skills.

Responsabilidades

• Lead and mentor CAPA management team to drive improvement and compliance.
• Oversee CAPA activities for complex QIs and sponsor audits.
• Collaborate with cross-functional stakeholders to close process gaps.
• Ensure proper reporting in eQMS and timely CAPA closure.

Conocimientos

CAPA Management

GCP guidelines

Root cause analysis

Quality investigations

Leadership

Audit & inspection

Excel

Communication

Educación

Bachelor's Degree

Herramientas

eQMS

Descripción del empleo

Sr. Quality Auditor, CAPA Centre of Excellence

Madrid, Spain
Lisbon, Portugal
Budapest, Hungary
Riga, Latvia
Zagreb, Croatia
Prague, Czech Republic
Sofia, Bulgaria
Athens, Greece
Ljubljana - Dunajska, Slovenia
Bucuresti, Romania
Full time
R
**Job Overview**
Lead and support effective corrective and preventive action (CAPA) management for significant quality issues (QIs) and audit and inspection responses including the assessment and review of investigations, appropriate root cause analysis and corrective and preventative actions. Provide support to management with insights, analyses and assessment and promotion of compliance with regulations, guidelines, and operating procedures through risk identification and mitigation, and improvement initiatives . Manage the quality assurance oversight of quality issues, audit responses, assignments, training and staff. Oversee and lead team management activities.

• Lead and mentor members of the CAPA management team, with a focus on driving improvement and compliance, ensuring an aligned approach to CAPA management and adherence to regulations and guidelines and providing support as needed.
• Lead and support CAPA activities for complex QIs and sponsor audits and inspections: assessing investigations, ensuring appropriate root cause analysis is performed, adequate corrective and preventative actions and effectiveness are implemented and followed up within the agreed timelines
• Collaborate with cross-functional stakeholders to identify process gaps, areas of improvements and ensure the application of quality processes, principles and strategy to support compliance with relevant regulations, GCP guidelines, procedures and sponsor agreements
• Ensure proper reporting and documentation of CAPAs in the electronic quality management system (eQMS) and that robust corrective and preventative actions and effectiveness checks are tracked and completed within the required timelines
• Promote a culture of proactive and continuous process improvement by identifying risks and trends, and optimizing the CAPA system and processes.
• Lead with a spirit of teamwork and collaboration to ensure effective communication among all department stakeholders and staff.
• Develop and/or provide training and guidance on Root Cause Analysis (RCA), CAPA management, execution, good documentation practices, and compliance adherence
• Develop and/or improve governing procedures, templates and work instructions, in order to streamline processes and drive compliance
• Advise Quality Assurance management on system audit needs.
• Support external and internal audits and inspections of IQVIA including inspections of IQVIA or investigational sites where needed, and ensure a state of inspection readiness at all times

• Bachelor's Degree
• **Extensive knowledge of CAPA Management, GCP guidelines and relevant regulations for the conduct of clinical trials is a must**
• Prior experience in audit and inspection management/support
• Root cause analysis and quality investigations
• Able to independently manage complex quality issues with minimal supervision
• Experience reviewing and driving CAPAs to closure
• 7 years Quality Assurance experience in pharmaceutical, technical, or related area with a focus on GCP in Clinical Trials.
• Background in science, healthcare and/or other relevant discipline and a detailed understanding of the clinical trial process and GCP guidelines
• Possess strong leadership and organizational skills for prioritizing workload and responsibilities.
• Excellent problem solving and root cause analysis skills.
• Excellent training and mentoring capabilities.
• Ability to handle multiple projects and work independently and effectively in a fast-paced changing environment
• Ability to speak effectively one-to-one, in group settings, with clients, vendors and employees of the organization.
• Proficient in Microsoft Office applications (Word, Excel)

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 .

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

At IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere. When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes. Likewise, as part of this culture, IQVIA is committed to ensuring effective equality between women and men, integrating it as a strategic principle in its corporate and human resources policies.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

EEO Minorities/Females/Protected Veterans/Disabled

Madrid, Spain
Lisbon, Portugal
Budapest, Hungary
Belgrade, Serbia
Tallinn, Estonia
Zagreb, Croatia
Riga, Latvia
Prague, Czech Republic
Sofia, Bulgaria
Ljubljana - Dunajska, Slovenia
Bucuresti, Romania
Full time
R
Plan and conduct independent clinical (GCP) audits to assess compliance with regulations, guidelines, and operating procedures. Prepare and distribute reports of findings to supervisor, operations staff, management, and customers. Provide consultation in interpretation of
regulations, guidelines, policies, and procedures. Support management in promotion and assessment of compliance to regulations, guidelines and corporate policies.

• Plan, schedule, conduct, report and close audit activities in any of the countries involved with IQVIA contracts to assess compliance with applicable regulations/guidelines, customer requirements, IQVIA SOPs and project specific guidelines/instructions
• Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers
• Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures
• Provide consultation to customers and monitors in interpretation of audit observations and formulation of corrective action plans
• Review, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans and track till closure for quality events arising from Audits; and from Quality Issues, Inspections or during similar QA activities as assigned.
• Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements
• Maintains the electronic quality management system (eQMS) and provides support in relation to the audit lifecycle
• Lead/collaborate/support in QA initiatives/projects for quality, process improvements
• Assist in training of new Quality Assurance staff
• May be required to manage Quality Issues
• May present educational programs and provide guidance to operational staff on compliance procedures
• May perform pre-inspection visits at sites, host audits/inspections; ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections, as assigned.

• **- The right candidate must be Certified to conduct audits in Italy in accordance with the Italian Decree of the Ministry of Health dated 15 Nov 2011.**
• - Travel 30-50% mainly in Europe.
• - 5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance Audits.
• - Experienced in the conduct of clinical trial Investigator site audits.
• - Experience in the conduct of clinical study report/data management clinical trial audits is preferred.
• - Knowledge of word-processing, spreadsheet, and database applications.
• - Extensive knowledge of pharmaceutical research and development processes and regulatory environments.
• - Knowledge of quality assurance processes and procedures.
• - Strong interpersonal skills.
• - Excellent problem solving, risk analysis and negotiation skills.
• - Strong training capabilities.
• - Effective organization, communication, and team orientation skills.
• - Ability to initiate assigned tasks and to work independently.
• - Ability to manage multiple projects.
• - Ability to establish and maintain effective working relationships with coworkers, managers and clients.

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 .

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

At IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere. When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes. Likewise, as part of this culture, IQVIA is committed to ensuring effective equality between women and men, integrating it as a strategic principle in its corporate and human resources policies.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

EEO Minorities/Females/Protected Veterans/Disabled