Qa Associate Director - Hosting Regulatory Inspections

Remote Opportunity - USA or Canada
Purpose:
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.
Responsibilities:

• Recommend systems for audit, write systems audit plans, coordinate scheduling, conduct, reporting and closure of internal system audits
• 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
• 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
• Provide Quality Assurance support, guidance and management of Quality Issues, as assigned
• Conduct trend analysis of audit results, provide to internal/external stakeholders as agreed, as assigned
• Promote the concept of quality, the principles of quality management and devise and implement quality improvements
• Oversee proper coordination of customer-initiated audits and mock regulatory inspections, manage regulatory facility inspections, as assigned
• Support Quality Management in proposal reviews and reporting QA metrics
• Oversee documentation, reporting, and closure of compliance issues
• Host customer audits and participate in review of corrective action plans, as assigned
• 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.
• 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
• Participate in or lead (cross functional) teams for special projects as assigned
• Serve as the QA Contact for assigned internal/external customers and IQVIA functional areas

Required Education and Experience:

• 3+ years of Line Management experience within Quality Assurance
• Or equivalent combination of education, training and experience
• Practical experience applying proactive quality approaches for clinical trials.
• Demonstrated experience Hosting Regulatory Inspections, specifically PV/Pharmacovigilance Inspections, and Sponsor/Customer Audits
• Bachelor's Degree in Scientific or Healthcare related field
• Thorough understanding of requirements of major regulatory agencies (FDA, EMA, PMDA, etc.) and demonstrated experience interpreting and applying relevant regulations, laws and guidance.
• 10 years of Clinical Quality Assurance experience from the CRO, Pharmaceutical, Biopharmaceutical, etc. industry, with a focus in development and Post-Marketing (Mainly Pharmacovigilance).

Required Knowledge and Skills:

• Strong knowledge of pharmaceutical research and development processes and regulatory environments.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Considerable knowledge of quality assurance processes and procedures.
• Excellent problem solving, risk analysis and negotiation skills.
• Knowledge of word-processing, spreadsheet, and database applications.
• Ability to influence and guide others.
• Effective organization, communication, and team orientation and leadership skills.
• Strong interpersonal skills.
• Ability to manage costs effectively through appropriate resource allocation.

Travel:

• Up to around 30%; Hosting 1-4 Inspections/Audits per month; Virtual and On-Site

Summary:
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.
#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