CAPA Manager at IQVIA

New York, New York, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, Clinical ResearchIndustries

Requirements

A minimum of a Bachelor’s degree in Science (BSc) or Arts (BA), or 6–8 years of relevant experience
At least 6 years of experience in the pharmaceutical industry, with 3–4 years of GxP experience in clinical research, development, or quality assurance
Experience in Quality Control and Compliance, Quality Assurance, CAPA processes, and/or Root Cause Analysis
Knowledge of the overall drug development process
Strong understanding of business processes and practices, including SOPs governing clinical research activities
Experience in quality assurance activities, such as audits of clinical investigative sites, systems and vendors, and audits of regulatory submissions
Ability to translate data into actionable insights and develop executable strategies
Strong conflict resolution, negotiation, and stakeholder motivation skills
Ability to independently plan, organize, and manage tasks

Responsibilities

Ensure services rendered adhere to applicable SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc
Act as process and system SME for the nonconformance and CAPA process and business/system requirements
Assist the Investigation Owner (IO) in the application of structured problem-solving methodologies in Root Cause Analysis (RCA) investigations (Fishbone, 5 Whys, etc.) independently or in support of the Root Cause Investigation team
Coach the Investigation Owner in understanding their end-to-end accountability of the entire CAPA process
Develop and maintain proficiency in the TrackWise ETS QEM system
Work with the organization to identify resources to support RCA investigations and resulting actions
Provide assistance to the record owner to ensure process requirements are met
Monitor nonconformance and CAPA deliverables/timelines for functional area by running reports, communicating upcoming deadlines to record owners, and escalating concerns to management as appropriate to actively drive compliance
Act as a liaison between the record owner and the quality leader; the record owner and the Root Cause Analysis group; the record owner and the TrackWise central entry team
Escalate any issues, as needed, to the BRQC CAPA Review Board
Raise any process or system questions or concerns to the CAPA Champions Community of Practice
Manage requests for assistance from the TrackWise central data entry team on behalf of the IO

Skills

CAPA

Root Cause Analysis

RCA

TrackWise

GxP

ICH-GCP

Fishbone

5 Whys

Quality Assurance

Quality Control

Compliance

SOP

Structured Problem-Solving

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

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