Global Development Operations Quality Manager

Dienstag, 22. Juni 2021
Donnerstag, 22. Juli 2021

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