Associate QA Director(GCP)

Job Level: Associate QA Director, GCP

Location: Home-based in the U.S. or Canada

Job Overview:
This position is an Associate QA Director in the Customer Strategy team who will serve as the strategic quality engagement lead for one or more key (i.e. accounts with established governance structures, account directors and multiple projects) IQVIA customers. The SEL role includes the following activities for the assigned customers:

Responsibilities:

• Collaborates with Quality counterparts at customers and with internal project teams to proactively promote, support and facilitate proactive quality through the identification and management of risks and implementation of quality improvement activities.
• Provides actionable insights from quality and operational data analysis and proactively working with the customer and the account team to develop action plans to drive continuous improvement.
• Analyzes trends in quality issue reporting and timeliness to ensure adherence to quality issue management requirements across project teams
• Supports the management and resolution of significant issues relating to quality.
• In collaboration with Quality Management, ensures projects are inspection ready starting at the design stage.
• Drives inspection readiness activities for the customer, including contributing to mock inspections by/of the customer
• Contributes to the development of the global risk-based internal audit plan.
• Advises customer Quality counterparts on the strategy for regulatory inspections and collaborates in the preparation for and management of inspections at customer offices and, as necessary, at investigator sites.
• Prepares for and actively participates in relevant Governance/partnership level meetings e.g., Quality Councils/ Joint Operations Committee (JOC) or equivalent meetings with customer Quality counterparts.
• Interfaces with senior management to discuss quality and compliance issues
• Interfaces with business development and operations to identify business opportunities
• Hosts and/or supports customer audits and ensures appropriate and sustainable action plans are developed and implemented.

Required Knowledge, Skills and abilities:
• Knowledge of word-processing, spreadsheet, and database applications.
• Strong knowledge of pharmaceutical research and development processes and regulatory environments.
• Considerable knowledge of quality assurance processes and procedures.
• Strong interpersonal skills and the ability to positively influence and guide others
• Excellent problem solving, risk analysis and negotiation skills.
• 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.
• Ability to coordinate timelines with internal customers and external vendors.
• Ability to manage multiple activities and timelines.
• Ability to articulate and define departmental needs and processes.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Required Education and Experience:

•  Minimum 10 years of experience in industry, with at least 3 years of experience in pharmaceutical, biotech, or other regulated industry with a focus on enterprise risk management activities
• At least 5 years’ experience in GCP Quality Assurance within pharmaceutical clinical research.
•  Considerable knowledge of GCP, clinical trial, regulations, and quality assurance auditing techniques.
• Demonstrated experience leading and successfully and timely delivering on implementation of cross-functional initiatives and programs with senior executive leadership visibility.
• Demonstrated expertise in implementing a quantitative approach to risk management.

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IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employ