Site Director, Quality Assurance & Systems

Mix Talent; Milpitas (CA); On-site; USD 180,000 - 230,000; Full time

Job summary

Mix Talent is seeking an Associate Director/Director, Quality Assurance to lead daily QA operations and strengthen quality systems for our contract manufacturing environment in Milpitas, CA.

The role combines hands-on quality oversight with cross-functional collaboration to support audits, inspections, and scalable quality processes. A strong background in GMP QA and leadership across QA/QC workflows is required.

Qualifications

• BS or MS in a scientific discipline such as Chemistry, Biochemistry, Pharmaceutical Sciences, Engineering, or related field.
• Typically 7–10 years of progressive GMP quality experience in QA, QC, or Quality Systems within pharma, biotech, or CDMO environments.
• Prior leadership experience overseeing quality operations, quality systems, or major quality workstreams.
• Working knowledge of product and material release, deviations, investigations, CAPA, change control, internal audits, inspection readiness, and QA/QC operational workflows.

Responsibilities

• Provide direct oversight of daily QA operations, incluing product and material release, deviations, investigations, CAPAs, complaints, change control, internal audits, and inspection readiness activities.
• Own the design, implementation, maintenance, and continuous improvement of core quality management systems, inclucing document control, change control, deviation and investigation management, CAPA, training, internal audit, and stability program administration.
• Lead and own the site’s deviation and investigation program; ensure deviations are captured completely and investigations are thorough with strong root cause support.
• Serve as the primary quality representative and front-room lead for regulatory and client audits and inspections, including FDA, EU, and other bodies; prepare and respond with robust CAPAs.
• Monitor evolving regulatory guidance (FDA, EMA, ICH) and translate into practical implications for quality systems and manufacturing controls.

Skills

Leadership

Cross-functional collaboration

QA operations

Communication

Education

BS or MS in Chemistry/Biochemistry/Pharma/Engineering

Tools

eQMS

LIMS

Job description

Mix Talent is seeking an Associate Director/Director, Quality Assurance to lead daily QA operations and strengthen quality systems for our contract manufacturing environment in Milpitas, CA.

The role combines hands-on quality oversight with cross-functional collaboration to support audits, inspections, and scalable quality processes. A strong background in GMP QA and leadership across QA/QC workflows is required.