Director of QA Strategy & Compliance

Miltenyi Biotec; San Jose (CA); On-site; USD 212,237 - 249,690; Full time

Benefits offered by this job

Health insurance

Vision insurance

Dental insurance

401(k) plan

Job summary

Miltenyi Biotec in San Jose, CA seeks a Quality Assurance Leader to oversee Quality Operations, ensuring compliance and quality management in pharmaceutical manufacturing. The ideal candidate will have over 15 years of experience in the field, with emphasis on regulatory compliance and QA leadership.

This role involves leading a high-performing team, maintaining an inspection-ready state, and engaging with regulatory bodies regarding submissions and audits. A comprehensive benefits package, including health, vision, and dental insurance, is offered.

Qualifications

• Approx. 15 years of experience in Technical Operations in the Pharmaceutical industry.
• 10+ years in Quality Assurance leadership roles.
• Experience with BLA/IND submissions and regulatory bodies.

Responsibilities

• Lead efforts to maintain an inspection-ready state.
• Oversee the quality management system.
• Build and lead a high-performing QA team.

Skills

Leadership skills

Knowledge of GxP requirements

Effective communication

Problem solving

Education

BS/Engineering or higher in relevant field

Additional qualifications in Quality Management or Regulatory Affairs

Job description

Miltenyi Biotec in San Jose, CA seeks a Quality Assurance Leader to oversee Quality Operations, ensuring compliance and quality management in pharmaceutical manufacturing. The ideal candidate will have over 15 years of experience in the field, with emphasis on regulatory compliance and QA leadership.

This role involves leading a high-performing team, maintaining an inspection-ready state, and engaging with regulatory bodies regarding submissions and audits. A comprehensive benefits package, including health, vision, and dental insurance, is offered.