Senior Manager, Quality Assurance - Product Disposition *PC

Your Role:

Miltenyi Biotec is seeking a strategic Senior Manager, Quality Assurance - Product Disposition to lead end-to-end batch record review, disposition, and release for cell and gene therapy products, ensuring inspection-ready compliance and on‑time delivery through cross‑functional partnerships. The ideal candidate brings deep technical expertise in clinical and commercial drug product release. As a people leader, the position recruits and develops talent, fosters an inclusive and high‑performance culture, and drives cross‑functional collaboration.

• Maintain complete and accurate QA documentation for drug product disposition activities, including batch records, investigations, and audit/inspection support records.
• Lead and manage a team of direct reports. Manage all aspects of employee work performance, including setting and monitoring performance goals; communicating job expectations; training, coaching and mentoring; disciplinary actions; and delivering performance evaluations.
• Conduct candidate interviews for various job postings and provide candidate evaluation/feedback. Make hiring decisions for vacant positions on their own team.
• Partner with Manufacturing, QC, Supply Chain, and other functions to ensure efficient, on‑time batch release and distribution readiness.
• Review release and QC testing data, trend results, and identify potential signals or emerging risks.
• Lead investigations for quality events impacting drug products and drive timely, compliant resolution.
• Approve final disposition and release of drug products to clinic and for distribution, confirming alignment with applicable quality standards and regulatory requirements.
• Draft, revise, and maintain SOPs and working instructions that govern disposition and release‑related QA processes.
• Develop strong working knowledge of drug substance /drug product manufacturing processes, including critical control points and key QA oversight points.
• Support audits and inspections by organizing, presenting, and explaining documentation and evidence of compliance.
• Communicate quality and disposition topics with internal partners and external stakeholders.
• Stay current on regulatory expectations, guidance updates, and industry best practices relevant to drug product quality assurance.
• Manage, train and mentor QA team members on product disposition and quality records.
• Identify and implement continuous improvement actions to enhance effectiveness and efficiency of disposition and release workflows.

• B.S. in Biology, or related field; 8+ years of experience in Quality Assurance, with a focus on Drug Product Disposition.
• 3+ years proven leadership experience managing teams and cross‑functional projects.
• Strong understanding of GMP principles and regulatory expectations.
• Excellent communication, strategic thinking, and problem‑solving skills.
• Skilled in building partnerships across departments and sites.
• Balances creativity with operational discipline to deliver results.
• Other duties as assigned.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle or feel;

reach with hands and arms, talk and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 15 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

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…