• Location: Hybrid (3 days/week in Needham, MA; 2 days remote)
• Type: Individual contributor (no direct reports)
• Salary: 258,333 - $280,000 + 25% bonus
Position Summary:
This is a highly visible, unique opportunity for a seasoned quality systems professional who
thrives in fast-paced, resourceful environments. You'll report directly to the SVP of Quality and
serve as a strategic partner across departments, while independently owning vendor oversight,
computer system validation, and overall GxP system effectiveness. You are a builder-of
systems, of processes, of trust.
We don't believe in micromanagement here. We believe in hiring people who take ownership,
follow through, and bring integrity to every detail. If you're ready to roll up your sleeves, drive
change, and help bring a life-changing oncology therapy to market, read on.
This is not a role for the average. This is a role for someone ready to help launch a first-in-class
therapy, and do it the right way.
What You'll Own
• Quality Operations Leadership:
Manage the end-to-end lifecycle of GxP systems across QA, Clinical Ops, CMC, and
Research, ensuring full compliance with 21 CFR Part 11 and modern industry standards.
• Vendor Oversight & Auditing:
Lead qualification, risk assessment, and ongoing oversight of a diverse ecosystem of
internal and external vendors-ranging from eQMS and EDMS to training systems,
supply chain tools, and cloud-based clinical applications.
• System Validation & Governance:
Own all CSV (computer system validation) activities, including SOP development,
vendor questionnaires, test scripts, reports, periodic reviews, and revalidations. Maintain
inspection-readiness at all times.
• Cross-functional Enablement:
Support scientific teams (PD, analytical, R&D) by ensuring vendor and data integrity for
BLA-enabling work. Bridge clinical and commercial quality expectations through
practical systems thinking.
• Training & Continuous Improvement:
Deliver GxP systems training and drive continuous improvement initiatives, trend
analysis, and knowledge management across the org.
• Documentation & Record Management:
Oversee document bundling, review, and archiving for key deliverables like batch
records, stability studies, and QA releases. Ensure audit-ready files and streamlined
workflows
What You Bring
• Bachelor's degree in Life Sciences or a related technical field.
• 10+ years of experiencein biotech/pharma Quality Assurance, with direct ownership of
GxP systems and a proven track record managing audits, vendors, and validations.
• Expertise witheQMS, EDMS, training systems, and other regulated platforms; familiarity
with stability, batch records, and clinical supply workflows.
• Background inclinical-stage or hybrid clinical/commercial environments, with a handson approach to QA operations and system management.
• Strong understanding ofICH, FDA, and Part 11 requirements, and how they apply to
cloud-based, outsourced, and evolving environments.
• Experience incross-functional quality enablement, supporting teams like PD, Analytical,
and Clinical in system compliance.
• Critical thinker with the ability to navigate ambiguity, prioritize work, and maintain
momentum without daily direction.
NOTE: All applicants must be authorized to work in the US and do not require sponsorship.
Unfortunately, we are unable to provide sponsorship of any kind at this time
