Senior Manager, Quality Assurance - Product Disposition PC 1562

Miltenyi Biotec • San Jose, CA

20d • $149,000 - $175,300

About The Position

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.

Requirements

• 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.

Responsibilities

• 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.
• Manages 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 provides candidate evaluation/feedback.
• Makes 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.
• Other duties as assigned.

Benefits

• In addition to your salary, the Company offers a comprehensive benefits package, including health, vision, and dental insurance, as well as a 401(k) plan.
• All benefits are subject to eligibility requirements.
• Certain positions may also be eligible for additional compensation such as bonuses or commissions.

What This Job Offers

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