Senior PM, GMP Verification & Qualification (Remote)

BioSpace; Boston (MA); On-site; USD 140,000 - 200,000; Full time

Benefits offered by this job

Fully remote work options

Office locations in Greater Boston

Generous flexible paid time off

Job summary

Syner-G is seeking a highly experienced Sr. Project Manager to lead the planning, implementation, and execution of an integrated Verification and C&Q program for large-scale GMP-regulated capital projects.

This role drives a verification-based approach that integrates commissioning and qualification from design through startup, turnover, and handover. You will establish verification strategies, manage scope, budget, and schedule, mentor multidisciplinary teams, and ensure alignment with ASTM

Qualifications

• 10–15+ years of GMP-regulated pharmaceutical or related project experience.
• Proven leadership of commissioning, qualification, verification, or validation on large capital projects.
• Strong knowledge of ASTM E2500 and risk-based qualification.
• Experience with Kneat or ValGenesis is preferred.

Responsibilities

• Lead the development and execution of an integrated Verification and C&Q program across the full project lifecycle.
• Establish verification strategies aligned with ASTM E2500 principles.
• Manage C&Q scope, budget, schedule, and risks.
• Mentor multidisciplinary C&Q teams and ensure cross-functional collaboration.

Skills

GMP Compliance

Project Leadership

Cross-functional collaboration

Regulatory understanding

ASTM E2500 knowledge

Education

Bachelor's Degree in Engineering, Life Sciences, or related technical discipline

Tools

Kneat

ValGenesis

Job description

Syner-G is seeking a highly experienced Sr. Project Manager to lead the planning, implementation, and execution of an integrated Verification and C&Q program for large-scale GMP-regulated capital projects.

This role drives a verification-based approach that integrates commissioning and qualification from design through startup, turnover, and handover. You will establish verification strategies, manage scope, budget, and schedule, mentor multidisciplinary teams, and ensure alignment with ASTM