Associate Director, Quality Assurance (Systems) *PC 494
Summary
Quality assurance leadership role at Miltenyi Biotec in Gaithersburg, MD: the Associate Director owns and improves the site's Quality Management System — document control, CAPA, deviations, audits, and inspection readiness — leading a team of QA specialists to keep GMP/GxP operations compliant. Core technologies include eQMS platforms (Veeva, MasterControl) and LMS administration.
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.
- 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.
Investigations, Documentation & Regulatory Compliance
- 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.
Cross-Functional Partnership & Quality Culture
- 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.
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.
Physical Demands:
Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature controlled, handicap-accessible facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in an office environment.The anticipated base salary range has been established at $167,780 - $182,548/year. The salary of the finalist(s) selected for this role will be set based on a variety of factors, including but not limited to, internal equity, experience, education, specialization, skills, abilities, and training. The above salary range represents the Company’s good faith and reasonable estimate of the range of possible compensation at the time of posting. In addition to your salary, the Company offers a comprehensive benefits package including health, vision, and dental insurance, plus a 401(k) plan. All benefits are subject to eligibility requirements. Certain positions are eligible for additional forms of compensation such as bonuses or commissions.
Miltenyi Biotec, Inc., is an EO Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity.The Company will provide reasonable accommodations to candidates and employees, unless doing so would impose an undue hardship on the Company, in accordance with applicable law.
Are you ready to start revolutionizing biomedical research? When you join Miltenyi Biotec, you join a family that is passionate about making a real impact – one breakthrough at a time. For over 30 years, we have played a pivotal role in the design, development, manufacture, and integration of products for sample preparation, cell separation, cell analysis, imaging, and cell culture needs. These developments have led to cutting-edge cell and gene therapies – transformative methods that mobilize the body’s own cells and genetic blueprint to tackle diseases such as cancer and autoimmune conditions. Today, our more than 18,000 solutions play a vital role in paving the way for the medicine of tomorrow.