Our client is a cell therapy company. They have asked us to assist them in a search for a Vice President, Quality.  

Major tasks and responsibilities include:

• Establishes the quality function and creates an overarching, phase-appropriate quality strategy to ensure R&D and commercial success.
• Is responsible for the implementation, development, and execution of a Quality Management System that incorporates all elements of GLP, GCP, and GMP compliance.
• Collaborates with other functions to provide quality oversight throughout the product lifecycle.
• Ensures all activities, processes, and procedures are carried out to the highest quality and accuracy standards and are in line with industry standards and compliance requirements.
• Develops and implements quality standards and processes that improve efficiency and compliance with regulatory requirements and industry quality standards.
• Manages quality assurance relationships with external partners.
• Proactively identifies potential quality risks to the operational plans and proposes options to mitigate risks.
• Proposes quality improvements to maintain compliance and improve efficiency as part of continuous improvement initiatives.
• Ensures FDA/EMA/ICH compliance and oversees inspection readiness activities.
• Is responsible for ensuring that all products are manufactured in compliance with cGMP and are consistent with applicable regulatory filings.
• Oversees qualification, quality agreements, performance tracking, and reviews of internal and external manufacturing and suppliers.
• Provides quality review of documents in support of regulatory submissions for investigational products, licensing applications, and periodic updates.
• Provides input to regulatory questions during the review period and product lifecycle.
• Oversees internal and external documents used in GMP activities.
• Represents GMP Quality during inspections.

We seek candidates with the following qualifications:

• A Bachelor’s degree is required. A Master’s degree is preferred.
• A minimum of ten years of experience with all Quality related facets of development and commercialization is required.
• Must have experience in Quality across GxP functions, including GMP, GLP, and GCP.
• Requires strong knowledge of US-FDA, ISO, ICH, GxP principles, and other global regulations for drugs and medicinal products and their application.
• Must have extensive CMC experience and the ability to define manufacturing practices and product specifications and ensures product safety.
• Experience hosting FDA regulatory inspections is required.
• Requires experience leading problem investigations, Root Cause Analysis, and CAPA.
• Must be able to manage affiliate and contract vendors and act as a liaison with regulatory agencies.
• Must thoroughly understand and apply principles, concepts, practices, and standards for testing in QC laboratories.
• An advanced understanding of regulatory and industry quality standards and associated processes is required.
• Technical knowledge of analytical method qualification, process validation, and establishing product specifications is required.
• Must have experience in strategic planning, risk management, and product development.
• Requires the ability to provide GCP compliance interpretation, consultation, training, and support to study execution teams.
• Must have expertise in manufacturing and controlling finished products, analytical analysis techniques, and statistical quality control.
• Requires a proven track record of partnering with internal and external stakeholders to solve complex operational issues and improve efficiency and compliance.
• Must have strong leadership, interpersonal, presentation, and communication skills and the ability to build and foster a quality culture.

 
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms and Forbes' list of Top 200 Best Executive Recruiting Firms.