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Leads early-phase Quality Assurance Operations for biopharmaceutical manufacturing, overseeing quality systems, lot disposition, GMP compliance, inspection readiness, investigations, corrective actions, client quality communications, training, staff development, and budget management. Ensures compliance with FDA, global regulatory authorities, ICH guidelines, and phase-appropriate GMP requirements for clinical programs and mammalian cell production.
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.
- 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.
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 - $244,000 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.
Avid Bioservices Tustin, California, USA Office
14191 Myford Rd, Tustin, California, United States, 92780 7020
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