Senior Director, Quality Assurance & Compliance

Miltenyi Biotec; San Jose; On-site; PHP 13,331,000 - 15,684,000; Full time

Benefits offered by this job

Health insurance

Vision insurance

Dental insurance

401(k) plan

Job summary

Miltenyi Biotec's San José site seeks a strategic QA leader responsible for Quality Operations, Quality Systems, and CMC oversight across CDMO manufacturing from starting materials to patient-ready products.

The role leads a high-performing team, ensures inspection readiness, regulatory filings support (BLA/IND), and collaboration with global Health Authorities, driving quality compliance and continuous improvement.

Qualifications

• 15+ years in Technical Operations with QA/QA leadership in Pharma, MedTech, or Lifescience.
• Experience authoring/approving BLA/IND submissions and responses to regulators (FDA).
• Experience maintaining a GMP/GDP Quality Management System and leading inspections.

Responsibilities

• Plan and ensure site inspection readiness and timely completion of audits.
• Develop and execute the site's quality and compliance strategy.
• Oversee Quality Operations, Quality Systems, and release activities.
• Advise site and functional leadership on regulatory strategy and risk.
• Own QA disposition and release decisions for GMP starting materials and products.
• Lead a high-performing QA team and drive training and development.

Skills

QA leadership

Regulatory strategy

Inspection readiness

Quality risk management

Cross-functional collaboration

Education

BS/Engineering

PhD or MS in related discipline

Tools

eQMS

Job description

Miltenyi Biotec's San José site seeks a strategic QA leader responsible for Quality Operations, Quality Systems, and CMC oversight across CDMO manufacturing from starting materials to patient-ready products.

The role leads a high-performing team, ensures inspection readiness, regulatory filings support (BLA/IND), and collaboration with global Health Authorities, driving quality compliance and continuous improvement.