Associate Director, Quality Assurance (Operations) *PC 483
Miltenyi Biotec

Your Role:

This position is primarily responsible for leading quality operations and compliance across the company's GxP activities, with a primary focus on GMP operations, and cGMP readiness in support of CGT and LVV manufacturing. This position supports activities related to pre-clinical, clinical and commercial manufacturing operations in accordance with US-FDA, EU, cGMP compliance and other applicable regulations.

The Associate Director, Quality Operations will report to the Senior Director, Quality Assurance and provide strategic operational leadership and oversight across assigned programs related to clinical and commercial. This role will lead day-to-day activities around clinical and commercial programs. They will work cross-functionally and with internal and external partners to ensure product quality throughout the development life cycle and provide strategic quality leadership aligned with company objectives.

Essential Duties and Responsibilities:

Quality Operations

• Oversee quality aspects of starting material, intermediates, drug substance and drug product manufacturing as well as packaging/labeling activities.

• Review and approve specifications affecting product quality and oversee the development of master batch records, process and method validation/protocol reports and other technical documents created to support all stages of the product lifecycle, from development to commercialization.
• Disposition clinical and commercial batches.
• Ensure effective CAPA management, change controls, deviations, and other GMP-related processes are followed during manufacturing and testing of products.
• Interact with manufacturing, clinical, or other functional areas that impact quality operations and provide support as needed.
• Perform risk assessments and implement appropriate quality and process controls to ensure proper oversight of production activities.
• Prompt communication to management of potential compliance issues.
• Participate in internal and external project team meetings.

Documentation and Record Control

• Perform periodic reviews and revisions of SOPs and policies, to align with regulatory updates and business needs.
• Manage other internal and external documentation related to QA operations.

Regulatory Compliance and Inspection Readiness

• Ensure Lentigen is inspection-ready, in compliance with regulatory requirements, and prepared for GMP audits or inspections from FDA or other international regulatory bodies.
• Support site preparation for regulatory inspections including personnel preparation and training.
• Participate in Quality Management Review meetings.

Operational Leadership and Continuous Improvement

• Drive continuous improvement initiatives across quality operations to enhance operational efficiency, reduce risk, and improve product quality.
• Provide strategic direction and hands-on leadership for operations teams, ensuring alignment with business goals and regulatory demands.
• Develop and implement metrics to monitor and report on the performance of Operations, identifying areas for improvement and ensuring corrective actions are implemented.
• Promote a strong Quality culture within the organization.? Identify compliance risks and be a part of the solution through ownership and collaboration.
• Lead, develop, and support quality assurance professionals; establish goals for the QA operations team supporting site and corporate goals.
• Lead and support quality activities on the manufacturing floor, including process validatio

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