We have partnered with an exciting, clinical-stage cell therapy biotech company dedicated to a bold mission of developing treatments for rare and devastating mitochondrial diseases. Our client's unique mitochondrial cell therapy technology is currently in clinical trials to treat a devastating rare pediatric disease, with promise to positively impact the lives of patients with many other kinds of mitochondrial diseases.
This global team is seeking a Quality Assurance leader to join their US team to collaborate with Manufacturing, Quality Control and cross functional leaders in producing clinical cell therapy product batches. The successful candidate will thrive in an early-stage clinical biotech startup environment and be an excellent team player with the ability to be a versatile hands-on leader. The candidate must have experience in the requirements of cGMP/GMP clean room environments, preferably with cell therapy, and will be a key team member in leading technology transfer activities as we set up manufacturing locations throughout the US. The successful candidate will be driven to thrive in an early-stage clinical biotech environment, be comfortable with ambiguity and will require flexibility in performing assigned tasks and skill sets across manufacturing and quality. The Head of Global Quality Assurance will primarily be responsible for:
Author and revise all controlled documents
Conduct vendor audits; ensure proper materials management and vendor qualification
Lead batch record review and lot disposition
Review all investigations and provide inputs into Corrective and Preventative Actions (CAPAs)
Contribute to the development of Quality Systems and procedures to ensure compliance with all cGxP, including tracking of all investigations, OOS, and CAPAs
Assist with implementation and maintenance of a document management system for Quality SOPs and other critical documents for training and review
Collaborate with process development scientists, Regulatory/CMC, and the head of manufacturing to perform tech transfers /transfer new processes into cGMP/GMP manufacturing environments
Provide support and documentation for all CMC-related regulatory requirements
Perform review of Quality Agreements
Train employees as required, promoting and educating on QA principles
Ability and desire to be hands-on and operationally strong
BS/BA in Science, Biology, Chemistry, Engineering or related field
6+ Years in Quality Assurance, management experience preferred
Experience in quality assurance in the pharmaceutical industry with manufacturing in a cGMP/ GMP environment is critical, cell therapy experience strongly preferred
Excellent organizational ability
Proficiency in MS Office suite and document management systems
Must be willing to travel domestically based on cell processing locations and tech transfer activities in the US up to 25%
Knowledge and Skills:
Teamwork – Ability to work well in a highly cross-functional team environment
Communication - Able to expresses one’s self clearly and concisely within team; timely and effectively communicates issues to supervisor
Ability to work in a fast-paced environment and work well under pressure
Analytical and Problem-Solving Skills - Able to troubleshoot critical issues or problems and determine causes and possible solutions using appropriate information
Organization – Exercises good time management and prioritization skills and can successfully manage multiple tasks simultaneously
Our client is deeply committed to workplace diversity and inclusion and is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
Job location: London Job salary: £30000 to £40000
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