QA Director - GCP Clinical Trials
Posted on: May 29, 2023
Home-Based - Remote Opportunity - USA and Canada
This QA Director will support IQVIA Biotech Customers, as well as be responsible for the Enterprise QA Audit Strategy. Provide direction in support of customer accounts with quality and compliance, and associated audit program where applicable. Provide insights, analyses and support in the promotion and assessment of compliance with regulations, guidelines, and operating procedures within Americas or Globally where applicable.
Establish and maintain strong working relationships with internal and/or external customer team leads and counterparts, as assigned
Provide actionable insights to customer counterparts, QA Leadership and Senior Management
Drive quality improvements and efficiencies along with risk mitigation based on QA data analyses, operational performance data, knowledge of process management, changing regulations and customer expectations
Provide consultation and support concerning compliance with regulations and appropriate controls, quality measures and risk assessment and mitigation in the development of improved or new service offerings across the business
Lead and project manage internal quality improvement initiatives as assigned
Assist in enhancement and establishment of quality assurance and control policy and risk identification and mitigation by providing consultation and recommendations to regional and Enterprise QA Leadership
Serve as author for QA Standard Operating Procedures (SOPs) as assigned
Serve as QA representative on Standard Operating Procedures (SOP) Taskforce(s) for other IQVIA functional areas as assigned
Participate in or lead teams for special projects as assigned. Teams may be cross functional.
Provide guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies
Conduct trend analysis of audit results and provide QA management with initial root cause analysis
May present trend analysis results and QA metrics and insights to IQVIA Senior management
May contribute to proper coordination of customer-initiated audits and mock regulatory inspections, and manage regulatory facility inspections
Recommend process and systems for audit, may contribute to the development of the related audit plans and oversee the delivery of these audits, review the Corrective and preventive actions (CAPAs) and ensure appropriate follow up
Plan, schedule, conduct, report and close internal/contracted GCP audit activities where applicable
May train/coach junior auditors to perform GCP audits in Americas
Manage staff in accordance with organization's policies and applicable regulations. Responsibilities include planning, assigning, and directing work, appraising performance and guiding professional development, rewarding and disciplining employees, addressing employee relations issues and resolving problems. Approve actions on human resources matters.
Oversee documentation, reporting, and closure of significant compliance issues, audit/inspection findings
Support QA Management Leadership in proposal reviews and reporting QA metrics and insights as assigned
Act as primary back-up for QA Leadership as assigned
Required Education and Experience:
Bachelors degree in life sciences or related field preferred
12 years Quality Assurance experience in pharmaceutical, CRO, biotech or related area
5 years of Line Management Experience
Or equivalent combination of education, training and experience.
GCP Auditing skills (Planning, preparation, conduct, reporting and follow up)
Ability to train and coach junior GCP auditors
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.
Effective organization, communication, and team orientation skills.
Senior Management experience in Quality Assurance.
Ability to influence and guide others at all levels of management.
Demonstrated ability to lead and manage multiple responsibilities.
Ability to manage costs effectively through appropriate resource allocation.
Ability to articulate and define departmental needs and processes.
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Domestic travel may be required. 2-3 times on average per quarter.
May also include some international travel.
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
Home-Based - Remote Opportunity - USA and Canada
Keywords: IQVIA, Nashville , QA Director - GCP Clinical Trials, Executive , Nashville, Tennessee
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