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

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. **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. - 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. **Education & Experience** - 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. **What We Offer** - Opportunity to join a mission-driven team where you'll contribute to impactful work, take on varied responsibilities, and grow quickly in a dynamic environment - 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 **Salary Range** The salary range for this position is $200,000 to $260,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. **Additional Description for Pay Transparency:** The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability. Subject to the terms of their respective plans, employees are eligible to participate in the Company's savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation - Unlimited PTO; Sick time - 10 days per calendar year; Holiday pay, including two Company shut downs; Parental Leave - 16 weeks within one year of the birth/adoption/foster care of a child; FMLA; Military Leave. Additional information can be found - https://www.crescentbiopharma.com/careers/#benefits #LI-CBIO