David Jasek

David is an expert in quality, with a decade+ of experience across multiple regulatory jurisdictions within the pharmaceutical industry. David joined Dark Horse in 2021, bringing experience in testing and commercial manufacture of API, IMP, and Drug Products as well as quality system design and implementation, validation, vendor management, inspection preparation, and remediation activities.

Since joining DHC, where he is now a Practice Expert, David has worked with cell, gene, and gene-modified cell products as well as device manufacturers supporting CGT operations. David uses his expertise to support clients of different sizes and stages of development with their project management, regulatory support, quality, manufacturing, and facility design needs.

As for David’s pre-DHC history, his previous non-quality roles spanned GMP production and distribution, including supervising the manufacture of growth media to support mycoplasma vaccine manufacture, sterile production and filling operations, and management of a pharmaceutical distribution center. David transitioned into quality roles in 2011, initially focusing on product complaints and investigations before moving into broader quality system design and continuous improvement activities in 21 CFR regulated environments.

In 2015, David relocated from Australia to the UK and supervised QMS activities at a large remote certification site. In addition to system design and reporting, David was also involved in and led oversight of the data migration and CSV of new electronic quality system and general systems integration between multiple large EU sites.

David’s last role before joining DHC was as a Quality Manager at an IMP manufacturer and contract testing site. The key responsibilities for this role included management of all client audits and responses, review and batch release of all IMP material and supporting clients during regulatory submissions. The role also included oversight of all quality activities, including raw material and release testing, stability study review and approval, equipment qualification as well as vendor review and approval.