Technical Product Manager GxP Software Systems (Drug Discovery)

Technical Product Manager GxP Software Systems (Drug Discovery)

Location: Hybrid- Boston office 1 day a week

Contract position- 6+ months

About BigRio:

BigRio is a remote-based, technology consulting firm with headquarters in Boston, MA. We deliver software solutions ranging from custom development, software implementation, data analytics, and machine learning/AI integrations. We are a one-stop shop that attracts clients from a variety of industries because of our proven ability to deliver cutting-edge and cost-conscious software solutions.

About the Role

We're seeking a Technical Product Manager with deep expertise in GxP-regulated software environments to lead the development and implementation of internal platforms supporting drug discovery and R&D operations.

In this role, you'll own the roadmap for validated systems, ensure adherence to SOPs, 21 CFR Part 11, and quality standards, and partner with scientific and technical teams to deliver compliant, high-impact digital solutions. You'll also oversee vendor collaboration and drive alignment between IT, QA, and business stakeholders.

What You'll Do

• Define and maintain product roadmaps for GxP-validated internal systems supporting discovery and development.
• Ensure all software development and deployment activities align with GxP, CSV, and internal quality processes.
• Lead validation strategy for new and existing systems including requirements traceability, risk assessments, and audit readiness.
• Partner with QA and Regulatory teams to develop and maintain SOPs, validation protocols, and release documentation.
• Oversee integration of cloud-based and high-compute environments within compliant frameworks.
• Collaborate with program management and scientific users to prioritize enhancements and ensure systems meet operational needs.
• Manage vendor relationships, contracts, and SLAs ensuring compliance and performance expectations are met.
• Support audits, CAPA management, and continuous improvement initiatives.

What You'll Bring

• 5+ years of product management or technical program management experience in biopharma technology.
• Strong working knowledge of GxP, 21 CFR Part 11, Computer System Validation (CSV), and quality management systems.
• Proven ability to lead software implementations in a regulated environment (LIMS, ELN, data analytics, or HPC platforms).
• Experience partnering across QA, IT, and scientific teams to balance innovation and compliance.
• Excellent organizational, communication, and stakeholder management skills.

Nice to Have

• Advanced degree in a technical or scientific field (MS, PhD, or MBA).
• Familiarity with cloud compliance (AWS/Azure/GCP) and validated SaaS systems.
• Experience implementing AI/ML or data-intensive systems under validation controls.
• Agile product management experience with tools such as Jira, Aha!, or Azure DevOps.