Director/Senior Director, Quality Management Systems, Digital QA and GxP Compliance

Job overview

The Director/Senior Director, Quality Management Systems, Digital QA and GxP Compliance role is onsite in Waltham, MA. The salary range is $200,000–$260,000 per year. The role is a key leader in Crescent Biopharma’s Quality organization, supporting its clinical-stage development programs. The position leads quality systems, digital quality assurance, GxP vendor oversight, and inspection readiness so systems remain compliant, fit for intended use, and scalable. It combines strategic direction with operational oversight, partnering across functions and with external vendors to strengthen quality processes and support the company’s development work.

What you'll do

• Lead the Quality Management System and associated digital platforms
• oversee system implementation, validation, periodic review, and lifecycle management
• maintain validated states through risk-based strategies and change control
• lead continuous improvement
• oversee GxP computerized systems, document control, training, deviations, investigations, and CAPAs
• report quality metrics and trends
• lead GxP vendor qualification and audit activities
• maintain the Approved Vendor List and quality agreements
• lead inspection readiness and support audits and regulatory inspections
• mentor QA staff and consultants.

What we're looking for

Skills & competencies

quality management systems

digital quality assurance

gxp compliance

quality assurance

vendor management

inspection readiness

biopharma

oncology

waltham ma

crescent biopharma

$200k–$260k per year

Work arrangement

• Weekend coverage required

Benefits & perks

• 100% employer-paid benefits package
• medical, dental, vision, life insurance, short- and long-term disability, 401(k), long-term incentives, unlimited PTO, 10 sick days, holidays, two company shutdowns, and 16 weeks of parental leave, subject to plan and policy terms.

Why this role

The posting describes a clinical-stage oncology company developing a pipeline that includes a PD-1 x VEGF bispecific antibody and antibody-drug conjugates.

About the employer

Crescent Biopharma is hiring for this role. Industry: Research and Development in Biotechnology (except Nanobiotechnology). Sector: 54.