QA Associate Director - Hosting Regulatory Inspections
Posted on: May 27, 2023
Remote Opportunity - USA or Canada
This QA Associate Director role is with the Client Audits & Regulatory Inspections (CARI) Team, part of Enterprise Quality Assurance. This QA Associate Director will support mainly the Hosting of Regulatory Inspections at IQVIA, specifically PV Inspections, as well as Sponsor and Customer Audits at the Sponsor. This person may also support Customer Audits at IQVIA if required. This will also be a Line Manager position.
Will provide insight, which is exercisable across the large part of the organization, or by managing a team of managers by influencing outcomes. Oversee & coordinate assigned QA program in support of customer accounts, functional accounts, audit and inspection program, or QA quality management system at a regional and/or global level. Provide insights, analyses and support in the assessment and promotion of compliance with regulations, guidelines, and operating procedures, risk identification and mitigation, Quality, Process, productivity/efficiency improvement initiatives. Act as line manager for one or more QA staff and oversee development and departmental deliverables. Manage the quality assurance oversight of projects, assignments, training and staff.
Plan, schedule, conduct, report and close audit activities, as assigned, in any of the countries involved with IQVIA contracts to assess compliance with applicable regulations/guidelines, customer requirements, Standard Operating Procedures ( SOPs) and project specific guidelines/instructions.
Host customer audits and participate in review of corrective action plans, as assigned
Provide Quality Assurance support, guidance and management of Quality Issues, as assigned
Recommend systems for audit, write systems audit plans, coordinate scheduling, conduct, reporting and closure of internal system audits
Serve as the QA Contact for assigned internal/external customers and IQVIA functional areas
Oversee proper coordination of customer-initiated audits and mock regulatory inspections, manage regulatory facility inspections, as assigned
Oversee documentation, reporting, and closure of compliance issues
Assist in the enhancement of Quality Assurance and control policy, and risk identification and mitigation by providing consultation & recommendations to regional and Global QA Management
Serve as an author for QA Standard Operating Procedures (SOPs), and act as regional QA representative to the global QA SOP taskforce
Provide guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies
Support Quality Management in proposal reviews and reporting QA metrics
Conduct trend analysis of audit results, provide to internal/external stakeholders as agreed, as assigned
Participate in or lead (cross functional) teams for special projects as assigned
Promote the concept of quality, the principles of quality management and devise and implement quality improvements
Manage staff, including planning, assigning, & directing work, appraising performance, guiding professional development, rewarding and disciplining employees, addressing employee relations issues & resolving problems. Approve actions on human resources matters
Required Education and Experience:
Bachelor's Degree in Scientific or Healthcare related field
10 years of Clinical Quality Assurance experience from the CRO, Pharmaceutical, Biopharmaceutical, etc. industry, with a focus in development and Post-Marketing (Mainly Pharmacovigilance).
3+ years of Line Management experience within Quality Assurance
Or equivalent combination of education, training and experience
Demonstrated experience Hosting Regulatory Inspections, specifically PV/Pharmacovigilance Inspections, and Sponsor/Customer Audits
Thorough understanding of requirements of major regulatory agencies (FDA, EMA, PMDA, etc.) and demonstrated experience interpreting and applying relevant regulations, laws and guidance.
Practical experience applying proactive quality approaches for clinical trials.---
Required Knowledge and Skills:
Considerable knowledge of quality assurance processes and procedures.
Strong knowledge of pharmaceutical research and development processes and regulatory environments.
Effective organization, communication, and team orientation and leadership skills.
Knowledge of word-processing, spreadsheet, and database applications.
Ability to influence and guide others.
Ability to manage costs effectively through appropriate resource allocation.
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Strong interpersonal skills.
Excellent problem solving, risk analysis and negotiation skills.
The IQVIA Quality Assurance 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.
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 Q - 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
Remote Opportunity - USA or Canada
Keywords: IQVIA, Minneapolis , QA Associate Director - Hosting Regulatory Inspections, Executive , Minneapolis, Minnesota
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