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Director, Quality Assurance

Clinovo
Clinovo
10+ years
preferred by company
Bakersfield
1 May 14, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance, Clinical Trials, Functional Teams, Literature Review, Management Skills, Medical Information, Medical Records, Medical Strategy, Pharmacovigilance, Regulatory Compliance, Risk Management, Safety Scien, Coaching Skills, Data Science, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Pro, Collaboration, Communication Skills, gmp, GMP Guidelines, Operational Excellence, Problem Solving Skills, Quality Agreements, Quality Compliance, Quality Management, Quality Standards, Regulatory Requ, Communication Skills, Continual Improvement Process, Master Data, Material Requirements Planning (Mrp), Materials Management, People Management, Production Planning, Supplier Relationship Management (Srm), Supply-Chain Man, CPC Certified, Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model

Director, Quality Assurance

Category: Quality Assurance
Location: Bakersfield
Job Type: Permanent

Job Overview

The Director, Quality Assurance will lead the GMP quality function, overseeing QA operations, batch disposition, product release, regulatory compliance, inspection readiness, and quality systems across internal and external manufacturing operations.

Key Responsibilities

  • Lead GMP quality strategy and compliance framework.
  • Oversee QA operations, batch disposition, and product release.
  • Build and manage scalable Quality Management Systems (QMS).
  • Ensure inspection readiness and regulatory compliance.
  • Support facility startup, GMP licensing, and commercial batch release.
  • Manage QA oversight of CDMO/CMO manufacturing partners.
  • Handle quality agreements, governance, escalations, and oversight.
  • Lead regulatory inspections and health authority interactions.
  • Manage deviations, CAPA, change control, SOPs, document control, and risk management.
  • Drive root cause investigations and corrective actions.
  • Monitor quality metrics, trends, and continuous improvement initiatives.
  • Partner with Manufacturing, Supply Chain, QC, Regulatory, and Technical Operations teams.
  • Build and lead a high-performing QA organization.

Required Skills

  • GMP Quality Assurance
  • Batch Disposition
  • Product Release
  • Quality Management System (QMS)
  • CAPA
  • Deviations Management
  • Change Control
  • Risk Management
  • SOP Management
  • Regulatory Compliance
  • Inspection Readiness
  • Health Authority Interactions
  • CDMO / CMO Oversight
  • Root Cause Analysis
  • Quality Metrics
  • Continuous Improvement
  • cGMP
  • ICH Guidelines

Experience

  • 10+ years in Quality Assurance / GxP leadership
  • Experience in pharmaceutical / biotech / biologics / advanced therapeutics
  • Direct experience in GMP QA operations and batch release
  • Experience handling regulatory inspections
  • Experience with startup / scale-up / commercial manufacturing environments
  • Experience managing external manufacturing partners (CDMO/CMO)

Education

  • Bachelor’s degree or higher in:
    • Life Sciences
    • Pharmacy
    • Chemistry
    • Biotechnology
    • Engineering
    • Related scientific discipline

Preferred Skills

  • mRNA / LNP / Biologics
  • Sterile / aseptic manufacturing
  • Veeva / TrackWise / QDocs
  • Australian regulatory exposure
  • Commercial manufacturing QA leadership