Associate Director, Quality Assurance (Operations) PC 483

Miltenyi Biotec • Gaithersburg, MD

4d

About The Position

The Associate Director, Quality Assurance (Operations) leads quality operations and compliance across the company’s GxP activities, primarily focusing on GMP operations and cGMP readiness for cell and gene therapy (CGT) and lentiviral vector (LVV) manufacturing. The role supports pre-clinical, clinical, and commercial manufacturing in accordance with US FDA, EU cGMP, and other applicable regulations. Reporting to the Senior Director, Quality Assurance, this position provides strategic operational leadership and oversight across assigned clinical and commercial programs, leading day-to-day activities and working with internal teams and external partners to ensure product quality throughout the development lifecycle.

The position oversees quality aspects of manufacturing, packaging, and labeling; reviews and approves specifications and technical documents; and supports batch disposition, validation, and GMP processes. It also leads documentation control, inspection readiness, continuous improvement, operational metrics, and development of QA professionals. The role represents the site in quality meetings with clients and engages with regulatory bodies as needed.

Requirements

• Bachelor’s degree in life science or engineering.
• At least eight years of leadership experience in Quality Assurance, cGMP compliance, or related fields in biopharmaceutical products.
• In-depth knowledge of the FDA, ICH, and EU regulatory environment for manufacturing medicinal or investigational products, specifically aseptically filled products.
• Strong leadership skills and demonstrated success managing a team.
• Demonstrated expertise in inspection readiness, regulatory inspections, and inspection-response management, including FDA Form 483 responses, commitments, and remediation strategies.
• Knowledge of Excel spreadsheet and MS Word processing software.
• Ability to organize and coordinate, plan and solve problems, manage frequent interruptions, supervise others, follow instructions, make quick decisions on complex issues, analyze and interpret data, and exercise sound judgment.
• Ability to use a keyboard, computer, and phone.
• Regular and predictable attendance and ability to work irregular hours that often include nights and weekends.

Nice To Haves

• Knowledge of the contract manufacturing business.
• Experience with biologics.
• Knowledge of SAP.

Responsibilities

• Oversee quality aspects of starting materials, intermediates, drug substance, and drug product manufacturing, as well as packaging and labeling activities.
• Review and approve product-quality specifications and oversee development of master batch records, process and method validation documents, protocols, reports, and other lifecycle documentation.
• Disposition clinical and commercial batches and help ensure timely product release against business and client commitments.
• Ensure effective management of CAPAs, change controls, deviations, and other GMP processes during product manufacturing and testing.
• Work with manufacturing, clinical, and other functional areas to support quality operations.
• Conduct risk assessments and implement appropriate quality and process controls for production oversight.
• Communicate potential compliance issues promptly to management and participate in internal and external project meetings.
• Periodically review and revise SOPs and policies to reflect regulatory updates and business needs, and manage other QA operations documentation.
• Maintain inspection readiness and support site preparation, including personnel preparation and training, for FDA and other regulatory inspections or GMP audits.
• Participate in Quality Management Review meetings.
• Drive continuous improvement initiatives to improve operational efficiency, reduce risk, and enhance product quality.
• Provide strategic direction and hands-on leadership for operations teams, aligning activities with business goals and regulatory requirements.
• Develop and implement operational performance metrics, report results, identify improvement areas, and ensure corrective actions are implemented.
• Promote a strong quality culture and address compliance risks through ownership and collaboration.
• Lead, develop, and support QA professionals and establish goals for the QA Operations team in support of site and corporate goals.
• Lead and support manufacturing-floor quality activities, including process validation, method validation, and technology transfers.
• Oversee QA Operations, raw material release, and QA Engineering.
• Represent the site in quality meetings with clients and engage with regulatory bodies and clients regarding site quality operations.
• Review and approve batch records, specifications, and QA, QC, and manufacturing SOPs for compliance with quality standards.
• Support the client complaint process and site and corporate quality operations improvement initiatives.
• Ensure site and corporate quality operations metrics are implemented, achieved, and reported at management meetings.

Benefits

• Health insurance
• Vision insurance
• Dental insurance
• 401(k) plan
• Certain positions may be eligible for additional compensation, such as bonuses or commissions.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior