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VP, Global Quality Management & Compliance - Iqvia Biotech (Europe)

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Primary Location: Stevenage, United Kingdom Additonal Locations: Amsterdam, Netherlands,NLD; Aschheim, Germany,DEU; Athens, Greece,GRC; Barcelona, Spain,ESP; Bratislava, Slovakia,SVK; Bucharest, Romania,ROU; Budapest, Hungary,HUN; Copenhagen, Denmark,DNK; Dublin, Ireland,IRL; Ljubljana, Slovenia,SVN; Milan, Italy,ITA; Oeiras, Portugal,PRT; Paris, France,FRA; Prague, Czech Republic,CZE; Riga, Latvia,LVA; Sofia, Bulgaria,BGR; Solna, Sweden,SWE; Warsaw, Poland,POL; Zaventem, Belgium,BEL Full time R1240576

Job description

IQVIA Biotech is a unique division specialising in working with smaller biotech and emerging biopharma clients and as such we have a vibrant, fast-paced working environment. The sector we work in is cutting edge with therapies for un-met medical need

We are looking for a VP, Global Quality Management (Global)

This role is critical to lead the Quality team requiring broad management and leadership skills across several areas. This involves recruiting a knowledgeable individual to lead multiple job areas with the ability to influence others to accept IQVIA practices and Biotech approaches on sponsor studies. Successful candidate should posses the ability tom apply a strategic view to the business whilst having proven skills of implementing major initiatives

Duites include:

• Lead Quality Assurance services, departments and functions associated with IQVIA Biotech quality management system throughout the global organization.

• Assure that functional manager(s) are empowered to lead the assigned team(s) and have adequate staff and resources to support their specific functional activities.
• Prepare QA budgets, monitor budgetary performance, and justify costs associated with activities within QA.
• Work with executive management, internal functional management, and the ISO registrar to achieve and sustain ISO 9001: 2008 certification throughout IQVIA Biotech locations.
• Direct the overall IQVIA Biotech quality management system activities.
• Assure that each IQVIA Biotech team establishes specific quality objectives, metrics, and milestones with the objective of surpassing client expectation in terms of service quality, efficiency and timelines.
• Participate in the planning of potential and awarded Quality Assurance service projects.
•Participate in new business development activities including, but not limited to, professional meeting/exhibition participation, client meetings, proposal preparation/presentation.
• Participate in strategic planning and plan implementation, as well as business optimization, to help assure the success of the IQVIA Biotech business enterprise.
• Help build a quality oriented, “can do” entrepreneurial team culture within the company to establish IQVIA Biotech as a leader among sophisticated clinical research service providers.
• Serve as a team member on clinical research projects. Provide the project team with quality and regulatory information, guidance, training, and support based on applicable regulations and guidance issued by regulatory agencies in the areas where IQVIA Biotech provides services.
• Determine need, develop and maintain applicable company policies, procedures, and SOPs, in compliance with applicable regulations and company strategies and philosophies.
• Ensure that IQVIA Biotech staff are adequately trained on IQVIA Biotech Policies, Guidelines, SOPs, Working Practices and applicable government regulations and guidelines; develop and provide training materials in GCPs, inspection readiness, electronic records and signatures and ISO 9001: 2008, as part of corporate orientation and on-going training programs.
• Manage the global quality assurance audit program at IQVIA Biotech; developing a yearly audit schedule, conducting and reporting quality assurance audits and audit follow up activities.
• Maintain a Corrective Action/Preventive Action Program.
• Oversee an effective and compliant computer systems validation program throughout IQVIA Biotech.
• Manage activities related to a centralized quality document control function within IQVIA Biotech.
• Identify and interpret regulations, directives, guidelines, and other pertinent information issued by applicable global regulatory agencies and other regulatory organizations as they pertain to the quality program and compliance activities.
• Perform other related duties as assigned.

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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.

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