Director, QMS, Digital QA & GxP Compliance

Crescent Biopharma, Inc.

Waltham (MA)

On-site

USD 200,000 - 260,000

Full time

14 days+

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Benefits offered by this job

Competitive compensation & equity

100% employer-paid benefits package

Flexible PTO and company shutdowns

Job summary

Crescent Biopharma, Inc. is seeking a Director/Senior Director, Quality Management Systems (QMS), Digital Quality Assurance and GxP Compliance.

You will lead the design, implementation, and oversight of Crescent's QMS, GxP digital platforms, and vendor management, ensuring validation, data integrity, and inspection readiness across a highly outsourced model. You will partner with IT and external vendors, drive continuous improvement, mentor QA staff, and align quality systems with evolving

Qualifications

Bachelor's degree in a scientific, technical, quality, or related discipline; advanced degree preferred.
8–10 years of progressive experience in Quality Systems and Digital Quality Assurance within biotech or pharmaceutical development.
Demonstrated expertise in QMS, GxP computerized systems, and data integrity principles.
Strong knowledge of FDA, EU regulations, ICH, GAMP, and phase-appropriate application.

Responsibilities

Provide leadership and oversight for Crescent's Quality Management System and digital platforms.
Serve as Quality Business Owner for Quality Systems including validation oversight and lifecycle management.
Ensure QMS and GxP digital systems remain validated with risk-based change control governance.
Lead continuous improvement across quality systems to enhance usability, compliance, and efficiency.
Provide QA oversight of GxP computerized systems including validation strategy and periodic reviews.
Lead Change Control activities for quality systems and digital platforms.
Develop, track, and report Quality System metrics to Quality Management and senior leadership.
Ensure document control and GxP training across all functions.