Senior Manager, Quality Assurance - Product Disposition *PC 1562

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.

Essential Duties and 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.

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.
• Other duties as assigned.

Physical Demands:

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.

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 hiring range for this position is expected to fall between $149,000 - $175,300/year, reflecting the range candidates can reasonably expect to be considered for at time of offer, based on factors such as experience, internal equity, and qualifications. 

The salary of the finalist(s) selected for this role will be set based on a variety of considerations, including but not limited to internal equity, experience, education, specialization, skills, abilities, and training. The above range represents the Company’s good faith and reasonable estimate 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, 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. 

Miltenyi Biotec, Inc is an EO Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity

Miltenyi Biotec, Inc. participates in E-Verify.

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. One integral division of that Miltenyi Biotec family is Miltenyi Bioindustry — our contract development and manufacturing organization (CDMO). As a full-scale CDMO, we provide customers with services for the development and manufacturing of lentiviral vectors and cell and gene therapy products. This crucial arm of our enterprise bridges the gap between research and mass bioproduction, ensuring that our solutions are accessible on a global scale. Miltenyi Bioindustry plays a unique role as both the producer and the service provider, relying on our instruments and reagents for each workflow step, controlling the entire supply chain and thus delivering greater security and planning clarity to our customers.