Director of Quality and Operational Excellence

For over 30 years, Reprotech has been the expert in long-term reproductive cryostorage. We are a trusted cryostorage facility that provides extended storage services to both IVF centers and oncology professionals. Operating across the United States, Reprotech maintains a substantial presence with five strategically located facilities, serving our valued patients and the network of esteemed reproductive laboratories with which we collaborate closely.

Position Summary

The Director of Quality & Operational Excellence is responsible for leading the organization's quality, safety, regulatory compliance, and continuous improvement initiatives. Working collaboratively across Operations, Quality, and Technology, this role develops and executes strategies that enhance operational efficiency, strengthen quality systems, reduce risk, and ensure patient and specimen safety. The Director drives a culture of continuous improvement, provides leadership across functional teams, and partners with organizational leaders to implement scalable solutions that support business objectives while advancing Reprotech's mission and values.

Detailed Duties & Responsibilities:

• Lead the organization's quality, operational excellence, and continuous improvement initiatives, partnering with Operations, Quality, Safety, and Technology teams to improve efficiency, reduce risk, and drive sustainable performance.
• Develop and implement operational excellence strategies, standards, and best practices that support organizational objectives and foster a culture of continuous improvement.
• Coach, train, and mentor leaders and staff on continuous improvement methodologies, quality principles, and operational excellence practices.
• Research, interpret, and apply applicable regulations, accreditation standards, industry best practices, and technical guidance related to cryostorage operations.
• Serve as the organization's Quality Management Representative, providing oversight of the Quality Management System (QMS) and core quality processes, including document control, training, change management, audits, investigations, supplier quality, CAPA, complaint management, and continuous improvement activities.
• Oversee document control, knowledge management, and forms management programs to ensure compliance and accessibility of policies, procedures, and training materials.
• Ensure organizational readiness for regulatory inspections, certifications, accreditations, and audits, such as FDA, ISO 9001 and ISO 13485, which will include the management of corrective actions and responses to findings.
• Monitor regulatory and industry requirements and integrate changes into quality systems, operational processes, and employee training programs.
• Lead quality risk management activities, investigations, root cause analyses, corrective actions, and quality event reviews to protect patient and specimen safety and ensure regulatory compliance.
• Audit and oversee controls related to specimen identity, traceability, chain of custody, transportation, storage, and handling practices.
• Develop, monitor, and communicate quality and operational performance metrics, KPIs, audit results, compliance risks, and improvement initiatives to executive leadership.
• Collaborate with the VP of Quality Assurance and organizational leaders to develop, implement, and evaluate quality and operational improvement programs.
• Travel to company sites as needed to assess compliance with company policies, procedures, and quality standards.
• Serve as Safety Officer, leading workplace safety programs, risk assessments, incident investigations, regulatory compliance activities, and continuous improvement efforts in partnership with Human Resources and Operations.
• Lead and develop quality team members through performance management, succession planning, professional development, workforce planning, and budget management while maintaining the highest standards of quality, compliance, and operational excellence.
• Other duties as assigned.

Reasonable accommodation may be given to qualified individuals with disabilities to perform the essential functions of the job.

Education/Experience

• Bachelor’s degree required; advanced degree preferred.
• Comprehensive working knowledge in job-related functional area; reproductive medical field, health services, biorepository, or laboratory, including quality systems.
• 10+ years of progressively responsible experience in Quality Assurance, regulated quality management systems, and regulatory compliance, including at least five years of leadership or management responsibility.
• Auditing skills, advanced training preferred.
• Experience with project management, driving continuous improvement initiatives while leveraging Lean / Six Sigma methodologies.
• Demonstrated experience managing regulated quality management systems, regulatory compliance programs, internal audits, CAPA processes, and risk management activities.
• Strong knowledge of applicable regulatory and accreditation requirements, quality management principles, and industry standards relevant to biorepository, laboratory, healthcare, or medical-device environments.
• Demonstrated success presenting quality metrics, compliance risks, and operational improvement initiatives to senior leadership.
• Ability to travel 25-35% of the time. Reprotech currently has 6 locations and travel to each location is required 2x/year for operational compliance to RTL policies as well as improve operational efficiencies.
• Ability to work independently as well as in a team to manage multiple priorities in a fast-paced environment.
• Approach problem-solving, new idea generation and analyses in a creative, credible and pragmatic way to guide team in solving complex problems while minimizing unproductive efforts (unnecessary analyses, re-work).
• Strong leadership presence, exceptional communications/interpersonal skills, and the ability to motivate/manage at all organizational levels.
• Ready to navigate complex solutions and create sustainable and scalable operational processes.
• Articulate, proactive, driven to succeed, and have exceptional attention to detail.
• Ability to delegate assignments and share decision-making with team members as appropriate.
• Be a curious collaborator and strong team player.