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Sr. Quality Auditor, GCP CAPA Centre of Excellence

On-site in Madrid·Full-time·Added 11 days ago (last checked 15 Oct)

IQVIA

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Our summary

Work mode: On-site, Madrid
Contract: Full-time
English: Required
Experience: Senior level
Education: University degree

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Skills

Requirements

What we're looking for

Extensive and demonstrable experience in GCP Quality Assurance within clinical trials, including expert knowledge of CAPA management, ICH-GCP guidelines, and global regulations governing the conduct of clinical research studies.
Prior audit and inspection management/support experience within a GCP-regulated clinical trials environment is required. Experience limited to GMP, manufacturing, laboratory, or commercial quality environments will not be considered.
Hands-on experience conducting root cause analyses and quality investigations related to clinical trial activities conducted under GCP requirements.
Proven experience reviewing, authoring, managing, and driving CAPAs to closure within a GCP clinical research environment.
Strong understanding of the end-to-end clinical trial lifecycle, including sponsor, CRO, investigator site, vendor, and regulatory oversight activities under GCP.
Demonstrated experience managing complex quality and compliance issues arising from clinical trial operations with minimal supervision.
Bachelor's Degree in a Life Sciences, Healthcare, Pharmacy, Nursing, or related scientific discipline.
Excellent problem-solving, risk assessment, and root cause analysis skills within a clinical research/GCP setting.
Proven ability to train, mentor, and advise stakeholders on GCP quality and compliance requirements.

The role

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.

Essential Functions

What you'll do

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

Hiring process

1 interview

Other interviews are conducted on Microsoft Teams, unless otherwise specified.
Most interviews are conducted in English unless otherwise specified. However, some questions may be asked in local language.
The use of AI support during an interview or online assessment is strictly prohibited and grounds for disqualification.

About IQVIA

IQVIA is a global leader in advanced analytics, technology solutions, and clinical research services to the life sciences industry. The company combines healthcare data, analytics, and technology expertise to help stakeholders in life sciences, including pharmaceutical companies, biotech firms, medical device manufacturers, and healthcare providers, drive healthcare forward. With over 90,000 employees worldwide, IQVIA operates in more than 100 countries, providing end-to-end solutions from clinical trials to commercialization.

In Spain, IQVIA has a significant presence with offices in Madrid and Barcelona, serving as a key hub for clinical research and healthcare consulting in Southern Europe. The company actively hires international professionals for roles in clinical operations, data management, regulatory affairs, and commercial consulting, offering a multicultural and English-speaking work environment. For international candidates, IQVIA provides a structured career path with opportunities to work on global projects, making it an attractive option for those looking to build a career in the healthcare and life sciences sector in Spain.

Industry: Clinical Research and Health Data
Founded: 1982
Employees: 50,000–100,000
Headquarters: Durham, USA
In Spain: Madrid, Barcelona

Good to know if you are moving

IQVIA operates in over 100 countries, offering international professionals the chance to work on global projects and potentially transfer between offices.
The company's Spain offices in Madrid and Barcelona are major hubs for clinical research and consulting in Southern Europe, with many roles requiring English as the working language.
IQVIA offers structured career development programs and a global mobility framework, making it feasible for international hires to progress within the company.
The company is a leader in healthcare data and technology, providing exposure to cutting-edge AI and data analytics applications in the life sciences sector.
Many roles in Spain are offered as remote or hybrid positions, providing flexibility for international candidates.

In their own words

About the company & team

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.

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.

All open roles at IQVIA