Director/Senior Director, QMS, Digital QA and GxP Compliance in Waltham, Massachusetts at Crescent Biopharma

• 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 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.

• 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.
• Demonstrated 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.

Please note:

Crescent Biopharma is an Equal Opportunity Employer. We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status.

Please note, Crescent does not accept unsolicited resumes from external agencies or recruiters. Submission of a resume without a prior written agreement does not create any express or implied contract between Crescent and the agency. Crescent will not pay any fees related to unsolicited resumes.

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