Director, Quality Assurance Operations

Avid Bioservices • Tustin, CA

1d • $165,600 - $186,300

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. Other Duties: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. The job description, shown above, is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.

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

• We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
• The compensation range for this role is $165,600 - $186,300 annually depending on experience and qualifications.
• Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.

What This Job Offers

• Job Type: Full-time
• Career Level: Director