Quality Operations Director, GMP & Compliance

Miltenyi Biotec; Gaithersburg (MD); On-site; USD 168,000 - 183,000; Full time

Job summary

Miltenyi Biotec is seeking an Associate Director of Quality Operations to lead quality activities across GMP/cGMP programs, including clinical and commercial manufacturing. The role ensures regulatory readiness and strategic leadership across CA/QA functions, partnering with internal teams and external partners to maintain product quality throughout development and commercialization.

The ideal candidate will drive continuous improvement, manage CAPA/change controls/deviations, and oversee

Qualifications

• Bachelor's degree in life science or engineering with eight+ years in QA, cGMP, or related biopharma fields.
• In-depth knowledge of FDA/ICH/EU regulations for medicinal or investigational products.
• Strong leadership with track record of managing teams and inspection readiness.
• Experience with contract manufacturing and preference for biologics; FDA 483 responses experience.
• Proficiency in Excel, MS Word, and SAP knowledge considered a plus.

Responsibilities

• Provide strategic leadership for GMP quality operations and CGMP readiness across clinical and commercial programs.
• Oversee quality aspects of starting materials, intermediates, drug substance/product, and packaging activities.
• Review specifications; approve master batch records; manage CAPA, change controls, deviations, and QA/QC documents.
• Ensure regulatory inspection readiness; support FDA/EU inspections and client audits.
• Drive continuous improvement; develop metrics and lead QA professionals on site and across programs.
• Lead manufacturing floor quality activities: validation, tech transfers, and batch release oversight.
• Represent the site in quality meetings with clients and engage with regulators as needed.

Skills

Leadership experience

Regulatory knowledge

GMP compliance

Quality systems

Process validation

Risk assessment

Cross-functional collaboration

Education

Bachelor's degree in life science or engineering

Tools

SAP

Excel

MS Word

Job description

Miltenyi Biotec is seeking an Associate Director of Quality Operations to lead quality activities across GMP/cGMP programs, including clinical and commercial manufacturing. The role ensures regulatory readiness and strategic leadership across CA/QA functions, partnering with internal teams and external partners to maintain product quality throughout development and commercialization.

The ideal candidate will drive continuous improvement, manage CAPA/change controls/deviations, and oversee