Director, QMS & GxP Digital QA

Crescent Biopharma; Waltham (MA); On-site; USD 200,000 - 260,000; Full time

Benefits offered by this job

Competitive compensation

Equity

100% employer-paid benefits

Flexible PTO

Company shutdown weeks

Professional development

Job summary

Crescent Biopharma is seeking a Director/Senior Director of Quality Management Systems to lead the design, implementation, and oversight of Crescent’s QMS and digital quality platforms. You will ensure data integrity, regulatory compliance, and scalable systems across outsourced operations, partnering with IT and external vendors.

You will drive validation strategies, risk-based approaches, and change control governance, while mentoring QA staff and advancing a culture of quality,

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/pharmaceutical development.
• Demonstrated expertise in Quality Management Systems, GxP computerized systems, and data integrity principles.
• Strong working knowledge of global regulatory requirements and guidance (FDA/EU/ICH/GAMP).
• Proven experience leading system implementations, validation strategies, and continuous improvement initiatives.
• Experience providing QA oversight of vendors and outsourced services (GxP vendor qualification, audits, CAPA).
• Experience leading Inspection Readiness programs and supporting regulatory inspections.

Responsibilities

• Provide leadership for Crescent’s QMS and associated digital platforms.
• Serve as Quality System owner for implementation, validation oversight, and lifecycle management.
• Ensure GxP digital systems remain validated and compliant with governance.
• Lead continuous improvement to enhance usability, compliance, and efficiency.
• Oversee QA of GxP computerized systems, including access reviews and inventories.
• Lead Change Control activities related to quality systems and digital platforms.
• Develop and report Quality System metrics to senior leadership.
• Oversee document control and GxP training across functions.
• Partner to develop and maintain policies, SOPs, and quality docs.
• Lead GxP training strategies, onboarding, and annual refresher programs.
• Oversee deviations, investigations, and CAPAs with root cause analysis.
• Support Quality governance forums with performance and risk assessments.
• Oversee vendor qualification, audits, and quality agreements; manage AVL.

Skills

Quality Management Systems

GxP compliance

Data integrity

Regulatory knowledge

Vendor management

Inspection readiness

Change control

Cross-functional collaboration

Risk-based validation

Quality metrics & reporting

Education

Bachelor’s degree in science/quality

8–10 years in biotech/pharma quality

Advanced degree preferred

Job description

Crescent Biopharma is seeking a Director/Senior Director of Quality Management Systems to lead the design, implementation, and oversight of Crescent’s QMS and digital quality platforms. You will ensure data integrity, regulatory compliance, and scalable systems across outsourced operations, partnering with IT and external vendors.

You will drive validation strategies, risk-based approaches, and change control governance, while mentoring QA staff and advancing a culture of quality,