Sr. Director, Quality Assurance Operations
Company: Avid Bioservices
Location: Costa Mesa
Posted on: April 3, 2026
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Job Description:
Description 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). Key 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. Required
Education and Experience: Bachelor’s degree in the life sciences or
other technical discipline. 15years 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. Position Type/Expected
Hours of Work: This role is a full-time, exempt position. Days and
hours of work are Monday through Friday, 8:00 AM to 5:00 PM. The
employee must also, if instructed, have the ability to work
overtime and/or weekends when necessary. Compensation: 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 $195,200 -
$219,600 annually depending on experience and qualifications.
Additionally, we offer opportunities for career growth and
development as well as a supportive and inclusive work environment.
Who you are: You have a "bring it on!" team player approach and an
unshakable positive attitude, always ready to tackle anything that
comes your way. Your written and verbal skills are out of this
world, and you communicate with clarity and confidence. You have
exceptional multitasking skills and an unparalleled attention to
detail that ensure the smooth running of everything. You are a
master at building relationships, capable of establishing
connections with anyone, be it team members, clients, vendors, or
suppliers. Physical Demands & Work Environment: In this dynamic
role, expect a blend of regular activities like sitting, standing,
and walking, with occasional physically engaging tasks such as
lifting objects up to 25 pounds. The work environment might expose
you to electrical shocks, toxic chemicals, vibrations, or loud
noise levels occasionally. However, reasonable accommodations are
available to enable individuals with different abilities to perform
effectively, ensuring a supportive and adaptable work setting. Your
visual acuity, including close, distance, and color vision, will be
essential in navigating through the diverse day-to-day demands of
this position.
Keywords: Avid Bioservices, Tustin , Sr. Director, Quality Assurance Operations, Science, Research & Development , Costa Mesa, California
