Sr. Director, Quality Assurance Operations

Avid Bioservices • Costa Mesa, CA

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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 Senior Director, Quality Assurance Operations Early Phase will provide leadership and management on a day-to-day basis responsible for Quality Assurance operations to include Quality Systems, Lot Disposition, and GMP Compliance. Ensuring manufacturing facilities and GMP operations maintain compliance with FDA and rest of world (ROW) regulatory agencies. The Sr. Director will interface with regulatory authorities during inspections and associated meetings. Responsible for resource allocation and interacting with other departments to facilitate phase-appropriate compliance activities for early phase clinical programs to include documentation, client communication, specifications development, addressing corrective actions, conducting investigations, etc. Provide both formal and informal training to coworkers on relevant processes (including quality systems, training, and GMPs).

Requirements

• Bachelor’s degree in the life sciences or other technical discipline.
• 15+years of multi-disciplinary experience in the pharmaceutical/biotechnology industry which should include at least 10+ years of line management experience in quality and/or regulatory compliance.
• Must have relevant experience in phase-appropriate GMP compliant quality management systems for early phase programs.
• Must have adequate experience and knowledge of US and ROW CGMP regulations and applicable guidelines for the production and control of mammalian cells.

Responsibilities

• Oversees Quality Assurance functions across all GXP processes.
• Responsible for planning, organizing, directing, controlling, and evaluating the activities and operations related to Quality Systems and programs.
• Facilitates continuous improvement by defining, implementing, and monitoring quality program indicators.
• Primary point of contact for clients with respect to quality issues.
• Oversees the systems and procedures that ensure phase-appropriate compliance with ICH guidelines, FDA and ROW regulatory authorities.
• Oversees product disposition activities of clinical products.
• Responsible for regulatory inspection readiness and for hosting and supporting those inspections.
• Manages and develops Quality Assurance staff, including identifying continuous improvement training opportunities.
• Responsible for budget oversight.

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.
• 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