Director, Quality Assurance Operations

Avid Bioservices

10d • $165,600 - $207,000 • Onsite

About The Position

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. 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.

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.
• Sound knowledge of cGMPs and equivalent regulations.
• Ability to communicate clearly and professionally both in writing and verbally.
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
• Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Proficient personal computer skills, including electronic mail, record keeping, routine database activity, word processing, spreadsheet, graphics, etc. Microsoft Office – Word, Excel, PowerPoint and Outlook preferred. Should also have working knowledge of Microsoft Project.

Nice To Haves

• Minimum of three years of supervisory/management experience.
• Six Sigma Black Belt Certification and 3+ years Operational Excellence experience.

Responsibilities

• Serve as the Quality representative on cross-functional and multi-site teams.
• Train personnel on relevant business processes and operational excellence principles
• Identify, design, champion, and implement process improvements using Operational Excellence tools (e.g. Six Sigma, Lean) to analyze current state and create future state.
• Analyze data, generate procedures, training materials, and other documents as appropriate to meet project stage gate deliverables
• Solve a wide range of difficult issues that impact multiple functions, following cGMP regulations and company standards
• Utilize regulatory intelligence and industry guidance to provide forward thinking guidance to continuous improvement initiatives
• Using technical and quality knowledge to provide QA oversight and guidance to real-time Manufacturing floor events resulting in rapid remediation and compliance to client and regulatory expectations. Communicate clearly with clients to support issue resolution and client relations
• Guide teams through systems transitions to support effective “right first time” roll out
• Independently formulate solutions to complex problems with little guidance or oversight required
• Strong problem solving and communication skills
• Perform other duties as assigned.
• Directs activities of functional areas for direct reports.

Benefits

• health, dental, and vision insurance
• 401(k) matching
• paid time off
• performance-based bonuses

What This Job Offers

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