Vice President, Quality
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:
We seek candidates with the following qualifications:
- 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.
- 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.
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