GCP Quality Risk Management- R&D

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GCP Quality Risk Management- R&D

Boston, MA

IDj-7393Posted 5/13/2025

This role requires candidates who are currently authorized to work in the U.S. without sponsorship, and C2C arrangements are not accepted.

General Summary

We are seeking a GCP Quality Risk Management- R&D professional to lead the development and implementation of an enterprise-level QRM framework in a GCP-regulated R&D environment. This role is pivotal in embedding quality risk principles into operational execution and strategic decision-making across clinical and R&D functions.

The ideal candidate is a self-starter who thrives in ambiguity, understands both regulatory expectations and business drivers, and can translate complex needs into practical, sustainable QRM processes and systems.

Key Responsibilities

Lead the creation, implementation, and refinement of QRM tools, frameworks, and governance processes aligned with regulatory expectations (e.g., ICH E6/GCP) and best practices.
Translate business, user, and functional requirements into QRM system design and manage implementation activities including configuration, validation, and UAT.
Partner with clinical and cross-functional teams to proactively identify and prioritize risks, guide risk mitigation planning, and drive risk review facilitation.
Conduct end-to-end process mapping and documentation, developing SOPs, procedures, and workflows to support scalable risk management.
Serve as a strategic advisor on risk issues, balancing compliance, operational feasibility, and business impact.
Leverage data and analytics to generate risk heat maps and dashboards, enabling data-driven decision-making.
Act as a subject matter expert and change agent, enabling the adoption of QRM thinking across R&D and Clinical functions.
Drive continuous improvement efforts using structured risk assessment tools like FMEA and RCA.
Support QMS-related initiatives with a focus on risk integration and system harmonization.

Qualifications

Bachelor’s or advanced degree in life sciences, quality, or a related discipline.
8–10 years of experience in Quality Assurance, Clinical Quality, or Risk Management within a regulated R&D or clinical setting.
Proven experience with QRM methodologies and platforms (e.g., Veeva QRM, TrackWise Digital, or similar).
Strong knowledge of GCP and ICH E6, with the ability to interpret and operationalize regulatory expectations.
Demonstrated ability to build new processes and frameworks in evolving or ambiguous environments.
Strong cross-functional collaboration skills with experience working across Clinical Operations, QA, and other R&D functions.
Excellent documentation and communication skills, with the ability to drive consensus and present risk information clearly to stakeholders.
Familiarity with Lean Six Sigma tools, risk analytics, and visualization techniques (e.g., risk heat maps) is preferred.

Key Traits for Success

Strategic thinker with hands-on execution ability
Emotionally intelligent, persuasive yet diplomatic
Curious, adaptable, and collaborative
Comfortable interpreting ambiguity as opportunity
Low-ego, mission-oriented, and proactive in driving change

Technical Skills

Risk Tools: FMEA, root cause analysis, risk registers/heat maps
Platforms: QRM systems (e.g., Veeva, TrackWise), general QMS systems
Data Fluency: Ability to interpret risk data for strategic insights
Software: MS Office Suite (especially Excel and PowerPoint)

Nice to Haves

Prior experience in a biotech or clinical-stage pharmaceutical company
Lean Six Sigma certification
Experience with global QRM teams and system validation activities
Background in Clinical Operations, Quality, or Ethics

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