Qa Associate Director - Customer Audit Hosting

Work From Home / Remote Opportunity for US or Canada

Job Overview:
The Quality Assurance Associate Director is responsible for hosting customer audits. This AD 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. Manage the quality assurance oversight of projects, assignments, training and staff.

Responsibilities:

• Oversee proper coordination of customer-initiated audits and mock regulatory inspections, manage regulatory facility inspections, as assigned
• Participate in or lead (cross functional) teams for special projects as assigned
• Support Quality Management in proposal reviews and reporting QA metrics
• Provide guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies
• Plan, schedule, conduct, report and close audit activities, as assigned
• Provide Quality Assurance support, guidance and management of Quality Issues, as assigned
• Host customer audits and participate in review of corrective action plans, as assigned
• Oversee documentation, reporting, and closure of compliance issues
• Promote the concept of quality, the principles of quality management and devise and implement quality improvements
• Conduct trend analysis of audit results, provide to internal/external stakeholders as agreed, as assigned
• Serve as the QA Contact for assigned internal/external customers and IQVIA functional areas
• Serve as an author for QA Standard Operating Procedures (SOPs), and act as regional QA representative to the global QA SOP taskforce
• 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
• Recommend systems for audit, write systems audit plans, coordinate scheduling, conduct, reporting and closure of internal system audits

Required Education and Experience:

• 10 years Quality Assurance experience in Pharmaceutical, Biotechnical, CRO or related area, including GXP QA experience
• Or equivalent combination of education, training and experience
• Bachelor's Degree, in health related field preferred

• 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.
• Demonstrated experience Scheduling, Planning, and Hosting Customer Audits
• Preferred experience in GCP, PV and other GxP Auditing.
• Tech savvy.
• Practical experience applying proactive quality approaches for clinical trials.
• Preferred experience in Real Word Data / Real World Evidence, Computer System Validation and hosting regulatory inspections

Required Knowledge, Skills and Abilities:

• Ability to coordinate timelines with internal customers and external vendors.
• Effective organization, communication, and team orientation and leadership skills.
• Possess applicable experience in conducting audits, writing audit reports and analyzing audits.
• Demonstrated ability to lead and manage multiple responsibilities.
• Identify functional constraints and identify solutions.
• Strong knowledge of pharmaceutical research and development processes and regulatory environments.
• Ability to articulate and define departmental needs and processes.
• Knowledge of word-processing, spreadsheet, and database applications.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Ability to manage multiple activities and timelines.
• Considerable knowledge of quality assurance processes and procedures'.
• Excellent problem solving, risk analysis and negotiation skills.
• Strong interpersonal skills and the ability to positively influence and guide others.

Travel:

• Up to around 30%

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.

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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