Director, Quality Assurance Operations

Avid BioservicesTustin, CA
7d

About The Position

Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. Your Role: The Director, Quality Assurance (QA) Operations will provide leadership and problem solving skills to drive strategic quality related initiatives. This role’s responsibilities are to serve as the architect and owner for quality enhancements while maintaining high standards of compliance. The Director will partner cross functionally with leaders and subject matter experts to successfully develop, implement, and champion the initiatives.

Requirements

  • B.A. or B.S. degree (preferably in Life Science)
  • 10+ years’ experience in the pharmaceutical or biotechnology industry, or an equivalent combination of education and experience, with five years in quality assurance.
  • Preferably a minimum of three years of supervisory/management experience.
  • Sound knowledge of cGMPs and equivalent regulations.
  • Ability to communicate clearly and professionally both in writing and verbally.

Nice To Haves

  • Six Sigma Black Belt Certification and 3+ years Operational Excellence experience preferred.

Responsibilities

  • Collaborate with Management to establish and report targets and timelines.
  • Serve as the Quality representative on cross-functional and multi-site teams.
  • Identify, design, and implement process and system improvements.
  • Train personnel on relevant business processes.
  • Use Operational Excellence tools (e.g. Six Sigma, Lean) to analyze current state and create future state.
  • Cultivate connections across the company and promote a culture of continuous improvement.
  • Generate procedures and other documents as appropriate to meet project deliverables
  • Solve a wide range of difficult issues that impact multiple functions, following cGMP regulations and company standards.
  • Follow company policies and procedures.
  • Perform other duties as assigned.

Benefits

  • health, dental, and vision insurance
  • 401(k) matching
  • paid time off
  • opportunities for career growth and development
  • supportive and inclusive work environment
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