Jobs NYC

Job Description

Insight Global is seeking a Senior IT GxP Program Manager for one of our healthcare clients that is focused on applying technology to drug development and building life sciences and health technology companies. This role will be fully remote and start as a six (6) month contract with potential extensions.

In this role, you will lead our clients effort in supporting Quality, Regulatory, Clinical, Medical Affairs, and Biometrics teams. This role will focus on developing and maintaining an integrated system landscape for our clients GxP environment, ensuring seamless data flow and compliance across functions. You will be responsible for architecting solutions that support our clinical and regulatory operations and help advance our clients mission. The ideal candidate will be well-versed in GxP system architecture and integration, with a strong focus on data flow, system interoperability, and a deep understanding of GxP requirements.

Key responsibilities will include:

• System Administration and Support:

o Administer and maintain GxP systems to ensure reliability, compliance, and data integrity.

o Monitor system performance and take proactive steps to address potential issues.

o Troubleshoot system issues and work with vendors for timely resolution.

• Solution Design and Implementation:

o Design and implement solutions to support Quality, Regulatory, Clinical, Medical Affairs, and Biometrics teams.

o Architect and maintain the integration of R&D and GxP systems, identifying and addressing gaps in the current system landscape.

o Provide technical guidance and expertise throughout the lifecycle of system implementations and enhancements.

• Integration Leadership:

o Lead integration efforts across GxP systems using tools like middleware integration platforms.

o Ensure data flows seamlessly between systems, leveraging the latest features and updates.

o Collaborate with external vendors and implementation partners to optimize system functionality.

o Evaluate and implement integration solutions that enhance scalability and efficiency as the company expands.

• Compliance and Data Governance:

o Ensure data integrity, security, and compliance for all R&D systems.

o Implement best practices for data governance and ensure that all systems meet GxP compliance requirements.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .

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Skills and Requirements

• 8+ years of experience in systems architecture/integration in a biotech or pharmaceutical company

• Experience overseeing/hands on in a Veeva implementation

• Experience with Veeva clinical, quality and regulatory systems (eTMF, QMS, RIMS)

• Strong understanding of GxP requirements, data integrity, and compliance - Ability to mentor/teach

• Chemistry, Manufacturing, Controls (CMC) experience null

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.