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We offer the exciting opportunity to join IQVIA™ as Quality Specialist or Senior Quality Specialist (m/w/d) and work in our German headquarter in Frankfurt or home-based throughout Germany.

The IQVIA Quality Management Team is carrying out and adopting the global Quality Plan according to the specific needs defined by the scope of the assignment, to assist the assigned business line staff in improving compliance with relevant regulatory requirements, and guidelines.

As a Quality Manager you will contribute to the development and be responsible for the implementation of specific quality improvement initiatives as agreed with the management of assigned business lines. You will provide advice and support to relevant key stakeholders with regards to quality control, risk assessment, risk management, and corrective/preventive actions.
 

RESPONSIBILITIES

• Adopt and implement the global Quality Management Plan within the scope of the assignment
  this will include:

• planning and executing the Quality Management activities
• risk identification and assessment through data review and quality control processes
• providing support in risk mitigation, in planning corrective/preventive actions, and guidance for improvement
• supporting the assigned business line management and staff to enhance effectiveness

• Cooperate closely with the relevant business and other stakeholders, support maintaining focus on quality in project delivery
• Contribute to the development and implementation of a Delivery Unit/Sponsor specific Quality Management plan and Risk Management Program, monitor the implementation and delivery
• Provide advice and support to teams within the assigned business line and other key stakeholders on all aspects of Good Clinical Practice (GCP) compliance
• Work in close cooperation with teams to manage non-compliance, quality issues and assist in planning corrective/preventive actions
• Inform the assigned business line and Quality Assurance of quality issues
• Work closely with Quality Assurance and assigned business staff in case of suspected misconduct, as required by the applicable SOPs
• May provide assistance during audits and regulatory inspections to the teams
• Prepare periodic reports to stakeholders on quality related matters, risk assessments and specific quality improvement initiatives
   

REQUIRED KNOWLEDGE, SKILLS AND EXPERIENCE

• University degree from life science-based subject
• Extensive working experience in clinical research, e.g. as Quality Manager and/or CRA/SrCRA
• Or an equivalent combination of education, training, and experience
• Sound working knowledge of medical terminology, International Conference on Harmonization (ICH), Good Clinical Practice (GCP), applicable regulatory requirements, quality management processes
• Knowledge of National and International Regulations and Drug Development processes as well as knowledge on pharmaceutical industry operations
• Excellent communication skills in German language (at least C1 level) including good command of English language
• Strong written and verbal communication skills
• Strong computer skills including a high proficiency in Microsoft Office applications
• Excellent organizational and problem-solving skills
• Effective time management skills and the ability to manage priorities
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
• Ability to lead and motivate a team
• Flexibility to travel within the region/country and driving license category B

Why join us?

Ongoing development is vital to us enabling you to have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set. Our benefits package is competitive, our scope is international, and we genuinely care about our people and their success. Working office-based or in home-office is possible.

Whatever your career goals, we are here to ensure you get there!

We invite you to join IQVIA™.

Please apply with your English CV, motivation letter and your certificates and reference letters.

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At IQVIA, 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. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.