Saviance · 2 months ago
Technical Product Manager – GxP Software Systems (Drug Discovery)
Boston, MA
Full-time
Hybrid
Senior Level
5+ years expBigRio is a technology consulting firm with expertise in delivering software solutions for various industries. They are seeking a Technical Product Manager to lead the development and implementation of GxP-regulated software systems that support drug discovery and R&D operations, ensuring compliance with quality standards and managing vendor relationships.
Information Technology & Services
Responsibilities
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
Qualification
Required
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
Preferred
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
Company
Saviance
Saviance is a modern consulting firm providing a variety of professional services to its clients in the US.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Rohit M.
Managing Partner
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