Hiring: Associate Director, Quality Assurance (Systems) *PC 494 Company: Miltenyi Biotec Location: Gaithersburg, MD Job Posted Time: 2026-09-11 14:04:47 Target Skills & Keywords : GCP, Quality Assurance, Regulatory Compliance, Risk Management About the job Experience: •8+ years of leadership experience in biotechnology or pharmaceutical environments, with exposure across GxPs (GCP, GLP, GMP) Required Skills: •Team Leadership •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. •Interface directly 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. Qualifications: •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. •Comprehensive expertise in 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. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!