About Company
This company is a promising biotech start-up that could make a significant impact on the field of biologics' delivery. Their technology has piqued the interest of many blue-chip pharma companies and multiple partnerships have already gotten underway.
The company is currently privately held; however, they've raised over $40 million in funding and are well-positioned for future growth.
About Position
They're seeking a Vice President, Head of Quality to support the development of their novel formulation platform. The individual will join a growing, multidisciplinary team of scientists/engineers and industry professionals.
A successful candidate will be an experienced leader responsible for overseeing all aspects of quality - including establishment of an integrated quality system, quality oversight of analytical method and product development, as well as internal and external manufacturing of our ultra-high concentration doses at selected Contract Development and Manufacturing Organizations (CDMOs).
Vice President, Head of Quality Responsibilities:
- As head of Quality, define and implement the quality road map for the company through the implementation of appropriate policies and procedures. This includes establishing a clear vision for the implementation of quality systems (document management, product release, investigations, etc.) and product lifecycle methodologies.
- Provide technical support and oversight for analytical methods development, product, formulation and process development, and manufacturing in support of the proprietary microparticle suspension technology. The scope of this function includes product investigations, lot release, material controls, R&D Quality, and data integrity.
- Support large scale process implementation at external CDMOs.
- Primary representative for the Quality Function with external partners.
- Provide cross-functional support of technology transfers for new processes or new equipment.
- Provide support and quality oversight of product, process, and component investigations.
- Establish phase appropriate requirements for R&D operations, specifically addressing material controls, lot release, and data integrity.
- Ensure quality posture of all critical suppliers, inclusive of contract service providers, is maintained through regular surveillance audits.
- Provide quality oversight to the coordinating, planning, and executing projects involving equipment changes and process improvements along with CDMO internal departments.
- Identify opportunities for process improvements, operational efficiencies, and lead implementation efforts.
- Execute, author, and/or review SOPs, work instructions, and policies as required.
- Support equipment, systems, and process validation activities, including review of equipment qualification documents, drafting user requirements, and participating in impact assessments.
- Experience and strong knowledge of Good Engineering Practices (GEP) requirements, definitions, specifications, design reviews, risk assessments, verifications, and change management
- Develop, generate, and manage Engineering deliverables through the manufacturing system lifecycle.
- Ability to identify and resolve immediate non-compliant existing conditions during site walks and construction field surveys.
Vice President, Head of Quality Qualifications:
- At a minimum a degree in science or engineering (chemical, biochemical, pharmaceutical mechanical).
- 15+ years' progressive experience in a quality function as a functional leader with broad experience working with complex biologics.
- Direct experience supporting clinical and commercial products and/or experience as a regulator is desired.
- Must have demonstrated competency in supporting aseptic processes (bulk manufacture, and fill finish) with a clear understanding of EU and US standards for aseptic processing.
- Must have experience supporting regulatory drug product approvals and new product applications (NDA, BLA).
- Clear understanding of cGMP compliance for biomanufacturing operations and facilities, with clear understanding of current trends in cGMP compliance.
- Experience establishing phase appropriate compliance requirements meeting EU and US regulatory requirements.
- Working understanding of complex unit operations, manufacturing systems and processes, and their control systems and how these are reflected in lifecycle documentation is essential.
- Ability to manage multiple projects at times, establish priorities, and meet deadlines to support our client/partner needs.
- Ability to think critically and demonstrate problem-solving skills.
- Ability to demonstrate strong leadership and team building skills.
- Excellent communication and listening skills across all levels Strong written and oral communication skills.
If you have an interest in changing patients' lives with disruptive biotechnology, please apply!!
