Quality Assurance Manager

IQVIA; Barcelona; Presencial; EUR 45.000 - 70.000; Jornada completa

Descripción de la vacante

A leading global provider in advanced analytics and clinical research is seeking a Quality Manager in Barcelona. This role covers the oversight of quality management systems, ensuring compliance with regulations while driving continuous improvement initiatives across multiple functions. Ideal candidates will have a Bachelor's degree and significant experience in the regulated life sciences sectors.

Formación

• 7 years of Quality Management experience in pharmaceuticals or related fields.
• Extensive knowledge of internal auditing and GCP regulations.
• Experience with software development processes and GAMP5.

Responsabilidades

• Oversee quality management system functions and internal audits.
• Provide guidance on compliance with regulations and training.
• Develop and maintain internal effectiveness review processes.

Conocimientos

Quality Management

Internal Auditing

Risk Assessment

Regulatory Compliance

Process Improvement

Educación

Bachelor's Degree in Life Sciences or equivalent

Descripción del empleo

We are seeking an experienced Quality Manager to oversee & coordinate assigned Quality Management system program elements in support of Patient Centered Solution functional areas, internal effectiveness review processes, audit support, and overall support of a healthy quality management system. This role shall participate in promotion of compliance with regulations, guidelines, internal written procedures, risk identification and continuous improvements initiatives.

Responsibilities

Provide guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, standard operating procedures, and policies.

Further develop, maintain and drive internal effectiveness reviews of internal processes / projects.

Oversee and participate in the documentation, reporting, and closure of compliance issues.

Organize and deliver training to other IQVIA departments concerning the activities of Quality services, results of activities, quality initiatives, GXP etc.

Ensure the follow-up of audit findings to ensure that appropriate actions have been taken and have adequately resolved the issues identified.

Evaluate policies and procedures for compliance with applicable regulations / guidelines and provide recommendations to management for continuous process improvements.

Write and revise quality management procedures as required.

Support assessing, mitigating risks identified within the applicable functional areas.

Define and solution efficiency and process improvements that will benefit multiple functions within the organization.

Participate in off the shelf software validation and risk assessment activities.

Plan, organize, and carry out internal audit / effectiveness checks of applicable functional areas.

Qualifications

Bachelor's Degree or equivalent working experience within regulated life science industries.

7 years Quality Management experience in pharmaceutical, medical device, technical, or related area. Equivalent combination of education, training and experience.

Extensive knowledge and aligned experience with internal auditing.

Knowledge of software development processes and GAMP5 requirements.

Knowledge and experience within a GCP regulated industry.

Considerable knowledge of quality management processes and procedures

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at

Quality Assurance Manager • Barcelona, Spain