What are the responsibilities and job description for the GCP QA Manager - Clinical Trial Regulatory Inspections position at IQVIA?
Remote Opportunity
Position Overview:
The Quality Assurance Manager for Regulatory Inspections is responsible for hosting regulatory inspections and hosting customers audits, when required. Managing QA oversight of projects, assignments, and training. Providing consultation in interpretation of regulations, guidelines, policies, and procedures. Providing support to management in the promotion and assessment of compliance with regulations, guidelines, and operating procedures.
Summary of Responsibilities:
- Scheduling, planning, and hosting regulatory inspections.
- Whenever necessary host customer audits.
- Maintain customer audit and regulatory inspection toolboxes.
- Evaluate inspection findings and prepare and distribute reports to operations staff, management, and customers.
- Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures.
- Provide consultation to customers, functional leads and monitors in interpretation of inspection observations and formulation of corrective action plans.
- Prepare, review and approve corrective action plans
- Present educational programs and provide guidance to operational staff on compliance procedures.
- Conduct quality assurance consultancy activities and projects for clients within budget and established timelines.
- Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
- Serve as author of Quality Assurance SOPs as assigned.
- Lead Projects.
- Train new staff, as required.
Required Education and Experience:
- Bachelor's Degree in a scientific or healthcare-related field Preferred
- 7 years Clinical Quality Assurance experience in Pharmaceutical, Biotech or CRO
Preferred Experience:
- Demonstrated experience scheduling, planning and hosting regulatory inspections.
- Thorough understanding of GCP, PV, and other relevant quality compliance requirements of major regulatory agencies (FDA, EMA, PMDA) and demonstrated experience interpreting and applying relevant regulations, laws and guidance.
- Practical experience applying proactive quality approaches for clinical trials.
- Preferred experience in Real Word Data / Real World Evidence, Computer System Validation and customer audit hosting.
- Preferred experience in GCP, PV and other GxP auditing.
- Tech savvy.
Required Knowledge, Skills and Abilities:
- Knowledge of word-processing, spreadsheet, and database applications.
- Extensive knowledge of pharmaceutical research and development processes and regulatory environments.
- Considerable knowledge of quality assurance processes and procedures.
- Strong interpersonal skills.
- Excellent problem solving, risk analysis and negotiation skills.
- Exceptional training capabilities.
- Effective organization, communication, team orientation, and leadership skills.
- Ability to work independently with initiative.
- Ability to manage multiple projects.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Travel:
- Up to 30-40%
Department Summary:
The IQVIA QA team is a dynamic, talented, and experienced global team that owns the global quality management system for the largest human data science company in the world. The QA function is responsible for driving compliance in a highly regulated industry through audits, hosting customer audit and regulatory inspections, functional support, issue & CAPA management, regulatory consultancy, management of data analytics and customer relationship interactions. These services ensure our clinical research activities are of the highest quality. We proactively support our business partners and help to drive innovation. Continuous improvement is a core capability and we value strategic thinking, creativity and operational excellence. We seek highly motivated people who truly want to make a difference in the life sciences industry and are looking for opportunities to impact the business and be part of the solution. At IQVIA, we support our colleagues with a focus on succession planning, career progression and continuous learning.
#LI-Remote #AmberPippin
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
As the COVID-19 virus continues to evolve, IQVIA's ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status
IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare - and human health - forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
Position Overview:
The Quality Assurance Manager for Regulatory Inspections is responsible for hosting regulatory inspections and hosting customers audits, when required. Managing QA oversight of projects, assignments, and training. Providing consultation in interpretation of regulations, guidelines, policies, and procedures. Providing support to management in the promotion and assessment of compliance with regulations, guidelines, and operating procedures.
Summary of Responsibilities:
- Scheduling, planning, and hosting regulatory inspections.
- Whenever necessary host customer audits.
- Maintain customer audit and regulatory inspection toolboxes.
- Evaluate inspection findings and prepare and distribute reports to operations staff, management, and customers.
- Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures.
- Provide consultation to customers, functional leads and monitors in interpretation of inspection observations and formulation of corrective action plans.
- Prepare, review and approve corrective action plans
- Present educational programs and provide guidance to operational staff on compliance procedures.
- Conduct quality assurance consultancy activities and projects for clients within budget and established timelines.
- Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
- Serve as author of Quality Assurance SOPs as assigned.
- Lead Projects.
- Train new staff, as required.
Required Education and Experience:
- Bachelor's Degree in a scientific or healthcare-related field Preferred
- 7 years Clinical Quality Assurance experience in Pharmaceutical, Biotech or CRO
Preferred Experience:
- Demonstrated experience scheduling, planning and hosting regulatory inspections.
- Thorough understanding of GCP, PV, and other relevant quality compliance requirements of major regulatory agencies (FDA, EMA, PMDA) and demonstrated experience interpreting and applying relevant regulations, laws and guidance.
- Practical experience applying proactive quality approaches for clinical trials.
- Preferred experience in Real Word Data / Real World Evidence, Computer System Validation and customer audit hosting.
- Preferred experience in GCP, PV and other GxP auditing.
- Tech savvy.
Required Knowledge, Skills and Abilities:
- Knowledge of word-processing, spreadsheet, and database applications.
- Extensive knowledge of pharmaceutical research and development processes and regulatory environments.
- Considerable knowledge of quality assurance processes and procedures.
- Strong interpersonal skills.
- Excellent problem solving, risk analysis and negotiation skills.
- Exceptional training capabilities.
- Effective organization, communication, team orientation, and leadership skills.
- Ability to work independently with initiative.
- Ability to manage multiple projects.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Travel:
- Up to 30-40%
Department Summary:
The IQVIA QA team is a dynamic, talented, and experienced global team that owns the global quality management system for the largest human data science company in the world. The QA function is responsible for driving compliance in a highly regulated industry through audits, hosting customer audit and regulatory inspections, functional support, issue & CAPA management, regulatory consultancy, management of data analytics and customer relationship interactions. These services ensure our clinical research activities are of the highest quality. We proactively support our business partners and help to drive innovation. Continuous improvement is a core capability and we value strategic thinking, creativity and operational excellence. We seek highly motivated people who truly want to make a difference in the life sciences industry and are looking for opportunities to impact the business and be part of the solution. At IQVIA, we support our colleagues with a focus on succession planning, career progression and continuous learning.
#LI-Remote #AmberPippin
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
As the COVID-19 virus continues to evolve, IQVIA's ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status
IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare - and human health - forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
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