GCP QA CAPA Manager

Related keywords: remote job qaquality assurance remote jobremote job project manager

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Job Overview

IQVIA is currently seeking a GCP QA CAPA Manager to join its team within Clinical Trials. This role involves supporting global investigations and processes related to Corrective and Preventative Actions (CAPA). As part of the IQVIA team, the successful candidate will play a crucial role in ensuring compliance with industry regulations, improving quality standards in clinical trials, and enhancing overall patient outcomes.

Responsibilities

As a GCP QA CAPA Manager, your primary responsibilities will include:

• Leading global investigations and supporting teams in the preparation of CAPA in accordance with regulations, customer requirements, Standard Operating Procedures (SOPs), and project-specific guidelines.
• Evaluating audit findings, preparing responses to operations staff and management, and managing Quality Issues and serious breach investigations.
• Conducting Root Cause Analysis (RCA) and reviewing effectiveness checks to ensure continuous quality improvement.
• Providing consultation on compliance status, regulations, and guidelines to project teams.
• Presenting educational programs and guidance on compliance procedures to operational staff.
• Maintaining the eQMS and overseeing updates related to quality events and audits.

Qualifications

To be considered for the role, candidates must meet the following qualifications:

• A Bachelor’s Degree in Life Science or a related field.
• At least 5 years of experience in GCP Quality Assurance within pharmaceutical or related fields, demonstrating a strong understanding of GCP and clinical trial regulations.
• Fluent English language skills to effectively communicate and collaborate within the team.
• Proficiency in MS Office applications, including word processing, spreadsheets, and database applications.
• Strong interpersonal communication and organizational skills to maintain effective working relationships.
• Ability to work independently while collaborating with various teams and stakeholders to address issues as needed.

Skills Required

In addition to the educational qualifications, several key skills are essential for the GCP QA CAPA Manager position:

• Strong problem-solving abilities and the capacity to think critically about compliance challenges.
• Effective communication skills that enhance collaboration among co-workers and management.
• Technical proficiency in quality management systems and audit processes.
• The ability to manage multiple tasks and priorities in a dynamic work environment.

Salary Information

The salary range for this position is competitive, with annualized base pay between $91,100.00 - $151,900.00. Actual compensation may vary based on qualifications, experience, location, and job-related criteria. Additionally, the role offers the potential for incentive plans, bonuses, and comprehensive benefits packages, ensuring a supportive work environment for employees.

Benefits and Work Environment

Working for IQVIA comes with several advantages, including:

• Consistent career growth opportunities that support personal and professional development.
• Flexible work schedules that promote a healthy work-life balance.
• A dynamic work environment exposing employees to new experiences and challenges.
• An attractive benefits package that includes health and welfare benefits aimed at ensuring employee well-being.

Conclusion

As a GCP QA CAPA Manager at IQVIA, you'll have the opportunity to significantly impact clinical research and the health industry. Leveraging your expertise in quality assurance, you will help develop and commercialize innovative medical treatments, thereby enhancing patient outcomes globally.

This position not only promises professional growth but also allows you to contribute to a vital field in the life sciences sector. With qualifications and skills aligned to this role, candidates can look forward to an enriching career journey at a globally recognized leader in clinical research.

This job offer was originally published on himalayas.app