Global Development Operations Quality Manager
Essential Functions of the Job (Key responsibilities)
• Point of contact for quality and compliance questions and work with QA to ensure alignment and consistent messaging to team based on GCP and regulatory requirements.
• Support team in identifying, escalating and putting risk plans in place to mitigate risks.
• Provide training to study teams, as needed
• Support teams in preparation for regulatory inspections of sponsor, country, site and vendor inspections
• Ensure adherence to GCP and overall quality as point of contact globally for sponsor study records.
• Support overall quality within on-going studies and submissions
• Work with teams to address quality issues with CROs and help teams bring them back in to compliance.
• Contribute and support facilitation, presentation and communication of lessons learned
• Derived proposals from Lessons Learn for process improvement
• Review critical/major findings with QA Audit reports to propose process improvement
• Support Teams in developing CAPA
• Collaborate with QA for information needed and requested for any global inspections
• Support teams in developing SOPs/WIs (global, regional, local)
• Review any SOPs/WIs development
• Support operational diagnostics to identify opportunities for improvement
• Provide input to Quality Plans
• Measure progress and targeting of results from improvement projects
• Develop matrix relationships to involve process experts and conduct improvement activities
• Ensure integration and alignment across organization
• Stay abreast of clinical trial requirements, FDA, EMA, ICH GCP, and guidelines from other regulatory agencies for the management of clinical trials within the US/EU and other regions, as appropriate.
• Become thoroughly familiar with assigned compounds and protocols.
• Facilitation and support of cross functional stakeholders
• Problem-solving and leadership to ensure continuous improvement
• Knowledge of relevant procedures
• High level of customer Service mindset
• Team Player
• Experience in managing complex and sensitive operational challenges
• Adapt at identifying issues, driving to root cause and able to drive solutions
• Well developed and effective verbal and written communication skills used in working with peers and
employees at all levels of the organization
• Broad knowledge of Clinical Operations
• Acute attention to details
Qualifications (Minimal acceptable level of education, work experience, and competency)
• Bachelor’s degree.
• 5 years’ experience in a pharmaceutical or bio-pharmaceutical company in a Quality role with a
minimum of 5 years’
• Understanding of Clinical Operations activities
• Experience with EMA, EU sponsor/site audits
• Experience in developing processes and/or SOPs and/or WIs
• Strong written and oral communication skills.
• Prior Regulatory inspection experience desired.
• Ability to travel
• Fluent in English
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.