Director​/Senior Director, QMS, Digital QA and GxP Compliance

Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s clinical-stage pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates. By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapies as single agents and as part of combination regimens to treat a range of solid tumors.

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We are seeking a Director/Senior Director, Quality Management Systems (QMS), Digital Quality Assurance and GxP Compliance to be a key leader within Crescent’s Quality organization, responsible for the design, implementation, and oversight of the Company’s Quality Management System (QMS), GxP digital quality platforms, GxP vendor management program, and inspection readiness activities.

You will provide strategic and hands‑on leadership to ensure quality systems and computerized/digital systems are fit for intended use, compliant with global regulatory requirements, and scalable to support Crescent’s clinical‑stage development programs. You will partner closely with cross‑functional stakeholders, IT, and external vendors to ensure appropriate validation, data integrity, vendor qualification and oversight, inspection readiness, and continuous improvement within a highly outsourced operating model.

• Provide leadership and oversight for Crescent’s Quality Management System, including document management, training, quality events, and associated digital platforms.
• Serve as the Quality Business Owner (or designee) for Quality Systems, including implementation, validation oversight, periodic review, and lifecycle management.
• Ensure QMS and GxP digital systems remain in a validated state through appropriate validation strategies, risk‑based approaches, and change control governance.
• Lead continuous improvement initiatives across quality systems and processes, identifying opportunities to enhance usability, compliance, and efficiency.
• Provide QA oversight of GxP computerized systems, including validation strategy, periodic reviews, user access reviews, system inventories, and inspection readiness.
• Lead and oversee Change Control activities related to quality systems and digital platforms.
• Develop, track, and report Quality System metrics and trends to Quality Management and senior leadership.
• Ensure effective document control and GxP training management across all functions, supporting consistent adoption of Crescent’s Quality System.
• Partner with functional teams to support the development, implementation, and maintenance of policies, SOPs, work instructions, and related quality documentation.
• Lead the development and execution of GxP training strategies, including onboarding, role‑based training, and annual refresher programs.
• Provide oversight of quality system deviations, investigations, and CAPAs, ensuring timely root cause analysis and effective remediation.
• Support Quality governance forums (e.g., Quality Review Boards), presenting system performance, compliance trends, and risk assessments.
• Provide QA oversight of vendors and service providers supporting QMS and GxP computerized systems, including qualification, audits, quality agreements, and performance monitoring.
• Own and lead Crescent’s GxP vendor management program, including coordination of all vendor qualification activities and management of the master audit schedule for GxP vendors and service providers.
• Ensure Quality Agreements are established, executed, and maintained with GxP vendors where required, partnering with Legal and Procurement as needed.
• Drive vendor audit CAPAs through to full closure, ensuring timely follow‑up, escalation of overdue actions, and verification of effectiveness.
• Maintain and continuously update the Approved Vendor List (AVL), ensuring accuracy and alignment with current vendor qualification status.
• Serve as the lead for Inspection Readiness across the Quality organization, ensuring a continuous state of inspection readiness, coordinating mock inspections…