Job Summary:

The Global Quality Manager, Development Operations provides global strategic and tactical leadership with our study teams and countries to achieve overall quality goals, support for regulatory inspections, process alignment and documentation. These activities will be in collaboration with Quality Assurance Group.

Essential Functions:
• 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

Skills:
• 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:
• 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

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 https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

The potential base pay range for this role, when annualized, is $103,900.00 - $218,400.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.