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Associate Director, QA(Clinical Research) at IQVIA

Associate Director, QA(Clinical Research)

IQVIA Durham, NC Full-Time

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, 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.

**Purpose** :

An Associate Director (AD) is responsible for:

+ Overseeing and coordinating assigned QA Audit program in support of customer accounts, functional accounts, audit and inspection program, or QA quality management system at a regional and/or global level.

+ Providing support to management with 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.

+ Acting as line manager for several QA Auditors, that includes training, sign off junior auditors and overseeing auditor development and audit team deliverables.

+ Collaborating with other QA team members to organize, resource audits as per applicable requirements.

**Summary of Responsibilities:**

+ Conduct GCP audits (e.g., investigator sites, eTMF, eCRF, process) on site or remotely, peer review audit reports, review and approve audit responses (CAPA).

+ Trains/sign-off junior auditors, peer review audit reports, review audit responses as part of the sign-off process for each type of audit.

+ Ensure the follow-up of major and critical audit findings to ensure that appropriate actions have been taken and have adequately resolved the issues identified.

+ Resources audits in Americas on a quarterly basis and on ad-hoc basis.

+ Assists Senior Management with the development of the annual audit program. Advise Quality Assurance management on system audit needs.

+ Provides guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies.

+ Evaluates policies and procedures for compliance with applicable regulations/guidelines.

+ Serves as author or reviewer of Quality Assurance Standard Operating Procedures (SOPs) as assigned.

+ Ensure the Quality Assurance database is maintained and up-to-date to reflect the status of audits being scheduled, auditor assignment and audit reporting and/or follow-up status.

+ Manages 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. Approves actions on human resources matters.

+ Travels to conduct audits or to accompany auditors in audits - 2 to 3/quarter in Americas.

**Required Knowledge, Skills and abilities** :

+ Thorough understanding of GCP, PV, and other relevant quality compliance requirements of major regulatory agencies (must: FDA, Health Canada, optional: EMA, MHRA) and demonstrated experience interpreting and applying relevant regulations, laws and guidance.

+ Practical experience in conducting internal process, investigator site, eTMF and vendor audits (on-site and remote where possible)

+ Practical experience applying proactive quality approaches for clinical trials.

**Required Education and Experience:**

+ Bachelor's degree in a scientific or healthcare-related field

+ Demonstrated experience leading and successfully delivering on GCP audits

+ Minimum 8 years of experience in experience in clinical quality in a pharmaceutical, biotech, or other regulated industry


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 [ Link removed ] - Click here to apply to Associate Director, QA(Clinical Research)

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. [ Link removed ] - Click here to apply to Associate Director, QA(Clinical Research) />
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. [ Link removed ] - Click here to apply to Associate Director, QA(Clinical Research) />
EEO Minorities/Females/Protected Veterans/Disabled

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