Your Role:
The Associate Director, Quality Systems develops, maintains, and improves the Quality Management system, supporting Technical Operations, Quality, and Clinical Development/Operations.
This individual plays an integral role in ensuring internal operations, processes and systems of the Quality department are flexible, functionable, and meet phase-appropriate compliance standards. This is a cross-functional role who serves as the primary liaison to internal and external customers for all Quality system related items associated with GMP and clinical operations.
The role will serve as subject matter expert on Quality Management Systems that will help power Bioindustry technology's continued success.
Essential Duties and Responsibilities:
Team Leadership
- Lead, mentor, and develop a team of Quality Assurance Specialists through coaching, performance management, goal setting, and professional development activities.
Quality Systems & Governance
- Lead Quality Systems and GxP Compliance operations, including Document Control, Training, Change Control, Deviations, OOS/OOT, CAPA, Risk Management and Product Complaint support.
- Develops flexible, phase appropriate site quality systems and processes applying processes and standards in alignment with the organization's strategy.
- Build and maintain quality programs and the internal Quality Management System. Responsible for electronic QMS deployment, administration, operation, and improvement. Communicates with other departments to resolve issues, identify and close gaps, and ensure ease of use of the QMS for personnel.
- Work with IT and external support services to configure the system over time as quality processes mature.
- Oversee the Change Control Review Board, CAPA Review Board and Management Reviews.
- Drive continuous improvement across vendor and internal quality systems, incorporating outcomes from Quality Management Review activities.
- Ensure all site-related quality documentation and records are completed thoroughly and in a timely way to maintain compliance.
Vendor & Quality Agreement Management
- Manage external oversight of GxP vendor quality systems.
- Author, maintain, and approve Quality Agreements with GxP vendors.
Audits & Inspection Readiness
- Lead internal and external GxP audit programs.
- Develop an audit plan, prepare audit reports, communicate findings, audit responses, compliance gap assessments including assessment of compliance risk to support key site stakeholders.