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

About the role

Crescent Biopharma is seeking a Director/Senior Director, Quality Management Systems (QMS), Digital Quality Assurance and GxP Compliance to lead the Company's Quality organization. The successful candidate will provide strategic and hands-on leadership to ensure quality systems and digital platforms are compliant with global regulatory requirements.

Responsibilities

• 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.
• 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.
• Maintain and continuously update the Approved Vendor List (AVL), ensuring accuracy and alignment with current vendor qualification status.
• Own and lead Inspection Readiness across the Quality organization, ensuring a continuous state of inspection readiness, coordinating mock inspections and readiness assessments, and helping the organization prepare for regulatory inspections or business partner audits and response.
• Support internal audits and regulatory inspections related to quality systems and digital quality platforms, including inspection preparation and follow-up.
• Ensure alignment of Quality Systems with evolving regulatory expectations, industry best practices, and Crescent’s stage of development.
• Contribute to departmental planning, including budgeting for systems, vendors, and resources.
• Mentor QA staff and external consultants and foster a strong quality culture grounded in accountability, collaboration, and continuous improvement.
• Stay current on global regulations, industry trends, and best practices related to Quality Systems and digital quality, driving continuous improvement within the QA function.

Requirements

• 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 Quality Management Systems, GxP computerized systems, and data integrity principles.
• Strong working knowledge of global regulatory requirements and guidance, including FDA, EU regulations, ICH guidelines, GAMP, and phase-appropriate application.
• Proven experience leading system implementations, validation strategies, and continuous improvement initiatives.
• Experience providing QA oversight of vendors and outsourced services, including GxP vendor qualification, audit programs, quality agreements, and CAPA management.
• Experience leading Inspection Readiness programs, including preparing organizations for regulatory inspections and driving cross-functional readiness activities.
• Experience supporting regulatory inspections and internal audits related to quality systems and computerized systems.
• Strategic, hands-on leader with the ability to balance long-term system strategy with day-to-day operational execution.
• Strong collaboration, communication, and influencing skills, with the ability to lead cross-functional teams.
• Ability to thrive in a fast-paced, evolving environment with changing priorities.
• Commitment to fostering a culture of quality, integrity, inclusion, and continuous improvement.

Qualifications

• Knowledge of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
• Experience with regulatory submissions and compliance with FDA, EMA, and other international regulatory bodies.
• Understanding of data integrity principles and practices.
• Experience with quality management software and systems.
• Experience with regulatory inspections and audit readiness.

Skills

• Strong leadership and project management skills.
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Proficiency in Microsoft Office Suite.
• Experience with quality management software and systems.
• Experience with regulatory inspections and audit readiness.

Benefits

• Competitive compensation, including base salary, performance bonus, and equity.
• 100% employer-paid benefits package.
• Flexible PTO; also, two, one-week company-wide shutdowns each year.
• A commitment to your professional development, with access to resources, mentorship, and growth opportunities.