AD/Director, Quality Assurance
Company: AdeptSource
Location: San Carlos
Posted on: April 1, 2026
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Job Description:
Title: AD/Director, Quality Assurance, Pharma Location: Redwood
City, CA Type of role: FTE, Full time Salary: 181K - 214K plus
bonus and equity Our direct client is seeking an Associate Director
/ Director Quality Assurance to join their growing company. Job
Description Develop and implement GXP including GMP quality systems
in accordance with ICH, FDA, EMA and global competent authority
regulations and industry guidance Review all GXP documents/reports
especially as they relate to method development, validation
activities and PPQ generation results Provide compliance oversight
for internal and contracted external GXP activities Coordinate and
implement audit plans and audit reports for all CROs, CDMOs, and
GMP vendors and internal departments. Coordinate and perform
virtual or on-site audits as needed Provide quality oversight for
GMP CDMOs (including quality agreements) and manage GMP product
batch record review and disposition. Lead and ensure inspection
readiness activities for all internal and external entities Host
GMP inspections. Follow up to any responses and CAPAs Develop,
implement, and manage the quality management systems including
vendor management, change control, product label review, risk
management, GXP computer systems, deviation and CAPA systems
Develop and implement overall GXP strategy, performance metrics,
analytics, and reports Ensure and record periodic SOP trainings for
all employees including onboarding FTEs and contractors in the GXP
system as applicable Qualifications Bachelor’s degree in biological
sciences or related field with minimum of 10 years’ experience in a
pharmaceutical setting. Proven, extensive knowledge of worldwide
GXP regulatory requirements, industry practices, and ability to
apply concepts. Experience with GMP regulations and current
industry standards. Experience in designing and implementing
quality systems and risk management tools Experience interacting
with and managing CMOs for DS and DP especially biological products
Experience leading/hosting US and international health authority
inspections/interactions Excellent interpersonal, verbal, and
written communication skills are critical in our collaborative work
environment Must demonstrate high organizational, prioritization
and management proficiencies Ability to deliver in a fast-paced,
small company environment and tenacity to seamlessly adjust
workload based upon changing priorities
Keywords: AdeptSource, Castro Valley , AD/Director, Quality Assurance, Science, Research & Development , San Carlos, California
