Director, Quality Assurance Operations

United States·Tustinexecutive

OtherQuality Assurance

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Quick Summary

Overview

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.

Key Responsibilities

The Director, Quality Assurance (QA) Operations will provide leadership and problem solving skills to drive strategic quality related initiatives.

Requirements Summary

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.

Technical Tools

OtherQuality Assurance

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.

Responsibilities

~1 min read

→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.

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.

Travel:
Occasional overnight travel by land and/or air may be required to attend seminars or conferences.

Requirements

~2 min read

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

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 unless otherwise stated by Supervisor. 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 $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.

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.