Job Description
Description Summary The Director of Quality Systems is responsible for strategic leadership, development, and oversight of a comprehensive Quality Management System (QMS) that supports We Are Sharing Hope SC’s mission, regulatory compliance, and continuous process improvement. This role fosters a culture of quality, collaboration, and accountability across all departments. The Director ensures adherence to all applicable regulatory, accreditation, and quality standards and serves as the organization's primary liaison to regulatory bodies and accreditation agencies. This position develops the confidences and cooperation of the staff at all levels to advance quality improvement efforts throughout our organization; leads culture change by serving as an advocate and resource for quality programs and philosophy; interprets regulatory statues and develops systems to ensure compliance.
The Director fosters a positive, inclusive, and collaborative work environment that supports innovation and integrity in all aspects of donation and transplantation services.
Essential Duties & Responsibilities Quality Systems Leadership: - Direct and enhance the Quality Management System in alignment with regulatory standards (FDA, CMS, UNOS, AOPO, AATB).
- Leads SHSC’s quality strategy, ensuring alignment with organizational objectives and compliance requirements.
- Champions a culture of continuous quality improvement and operational excellen ce.
- Maintains knowledge of procedures related to organ and tissue products.
- Oversees the revision and maintenance of the Quality Systems Manual.
- Reviews and approves all policies and forms to ensure compliance with all applicable regulations and integration/compatibility with existing systems.
Quality Program Management: - Oversee key quality programs including document control, internal auditing, non-conformance, complaints, vendor qualifications, external audits and risk management.
- Ensure systems are in place for equipment validation, chart reviews, training compliance, and policy development.
- Reviews and approves policies and forms as needed, to ensure compliance with all applicable regulations and integration/compatibility with existing systems.
Regulatory Compliance & Accreditation: - Maintain and interpret current knowledge of regulatory and accreditation standards; translate requirements into compliant operational policies and procedures.
- Lead the organization through regulatory inspections, accreditation surveys, and internal audits, ensuring sustained readiness and a strong compliance posture.
- Ensures all required, regulatory, and governmental licenses are kept current and assists in developing action plans to achieve new accreditations.
- Assists management and others with the development of appropriate corrective actions for inspection findings.
- Establishes and maintains our complaint and non-conformance system and proposes additional corrective actions, tracks trends, and ensures necessary reports are filed with regulatory agencies.
- Manages vendor qualification program to ensure SHSC maintains or exceeds compliance and accreditation standards.
Performance Improvement & Accountability: - Direct the organization’s performance improvement (PI) program, ensuring quality indicators, benchmarking data, and key metrics are consistently monitored and acted upon.
- Partner with leaders to define performance goals and improvement plans; track corrective/preventive actions (CAPAs) and ensure timely resolution of quality concerns.
- Present quality dashboards and trend reports to executive leadership to drive strategic improvements and informed decision-making.
Training & Staff Development: - Hire, mentor, and develop high-performing quality staff; provide regular coaching and professional development opportunities.
- Oversee the development and delivery of new hire and ongoing quality-related training across the organization.
Strategic Planning & Budgeting: - Develop and manage the Quality Systems strategic plan and annual departmental budget.
Culture and Collaboration: - Foster a positive, respectful, and collaborative team environment within the Quality Systems department and across the organization.
- Encourage staff engagement, recognition, and transparent communication in all quality initiatives and interactions.
- Build effective partnerships with clinical, operational, and administrative teams to embed quality into daily practice and innovation.
- Align departmental goals with SHSC’s mission, vision, and long-term organizational strategy.
Committee Participation: - Actively participate in SHSC’s Corporate Compliance Committee, Safety Committee, and other leadership groups to ensure quality integration.
- Other duties as assigned.
Qualifications Qualifications, Education & Experience - BS Degree;
- Five (5) years of experience in a cGMP or cGTP environment such as tissue banking, organ donation, blood banking, pharmaceutical or medical device;
- Three (3) years of QA, QC, or quality auditing management experience required;
- One (1) recognized accreditation in a related field;
- Operational knowledge in biologic manufacturing required; or,
- An equivalent combination of education and experience.
Job Tags