Director, Head of Global Quality Assurance

​The opportunity:

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:

Responsibilities:

• 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

 Basic Requirements:

• 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.