Associate Director, Quality Assurance (Systems) PC 494

Miltenyi Biomedicine•Gaithersburg, MD

2d•$167,780 - $182,548•Onsite

About The Position

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.

Requirements

Bachelors in a life science from a four-year college or university; 8+ years of leadership experience in biotechnology or pharmaceutical environments, with exposure across GxPs (GCP, GLP, GMP)
Demonstrated leadership experience with direct ownership of QMS and quality systems.
Deep understanding of global regulatory requirements, including FDA CFRs, ICH guidance, and EU Annex requirements.
Proven experience in Quality Systems Management; implementing and managing eQMS platforms (e.g., Veeva eQMS, MasterControl) and Learning Management Systems.
Strong strategic and operational capability, balancing vision-setting with hands-on execution.
Proven ability to manage multiple complex initiatives in a fast-paced, dynamic environment.
Strong judgment and risk management skills, balancing compliance, science, and business needs.
Strong written and verbal communication skills with the ability to influence senior and cross-functional stakeholders.
Highly proactive, accountable, and comfortable operating with a high degree of autonomy.

Responsibilities

Lead, mentor, and develop a team of Quality Assurance Specialists through coaching, performance management, goal setting, and professional development activities.
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.
Manage external oversight of GxP vendor quality systems.
Author, maintain, and approve Quality Agreements with GxP vendors.
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.
Oversee inspection readiness activities, including mock audits and SME preparation.
Support and host regulatory inspections and client audits. Interact with regulatory agencies/clients during inspections and prepare responses using robust systems and metrics.
Drive timely and effective CAPA completion across the organization.
Review and approve OOS investigations, deviations, and product complaint investigations.
Write, review, approve, and maintain GxP SOPs and GxP policies.
Lead participation in Annual Product Quality Review activities.
Provide quality and GxP compliance guidance to cross-functional partners across Regulatory, Technical Operations, and Commercial.
Ensure GxP employees complete required training.
Contribute to building a high-performing quality organization and models a culture of accountability, transparency, and continuous improvement.
Represent QA in internal and external meetings.