Barry Oliver - Dark Horse Consulting Group

0

years of experience

0

years at DHCG

Barry

's Service Domains

CMC

薬事

品質とコンプライアンス

ビジネスアナリティクス

Barry is a seasoned Executive Global Quality leader in the pharmaceutical industry. He brings to DHC broad experience in CGT, biological, sterile injectable and solid dose manufacturing, packaging, and distribution. His 20+ years of experience was gained in the context of the CDMO space, having held multisite, multi-modality corporate quality and compliance responsibilities across UK-, EU-, and US-based facilities supporting customers and partners to produce high quality clinical and commercial medicinal products. Barry's modus operandi is making action happen through tight collaboration and partnership. He also has extensive technical and operational quality experience at site level, having held Site Quality and Production Leadership roles, and is an eligible Qualified Person, Responsible Person, and Controlled Drug Authorised Person.

Prior to joining Dark Horse in May 2025, Barry was a member of a hand picked leadership team that was charged with setting up the Catalent Cell & Gene Therapy Division. His role as VP of Quality involved forensic due diligence activities as part of worldwide M&A, speedy but robust site integrations, and establishing high performing quality teams to support the growth engine of the business. The bio network brought together 7 different companies that combined to provide iPSC, Cell Therapy, Plasmid and Gene Therapy development, manufacturing and testing services. This also involved support for the build out of new facilities from ground up and retrofit of existing facilities through to licensure in EU and North America in record time. Following several promotions and role expansion in his time at Catalent, Barry was given responsibility for Catalent Biological Drug Substance sites (mammalian, microbial, mRNA,LNP), BioAnalytics Centre of Excellence (including next generation analytics) and BioProducts.

Prior to Catalent, Barry was employed by Aesica/Consort Medical (now Recipharm) as VP Quality, ultimately with responsibility for all Quality and Regulatory Affairs matters in the company. The portfolio of sites was wide ranging and Barry was responsible for small molecule as-well as large molecule manufacturing, packaging and testing facilities. He also established centralised functions including Regulatory Affairs, Auditing (internal, regulatory and vendors), Data Integrity, Computer System Validation and implementation of a harmonised electronic Quality Management System, a QP training programme and coordinated the companies response to Brexit. In this role he led the company inspection readiness programmes and enjoyed successful inspections from all main regulatory agencies worldwide, MHRA, FDA, PMDA, ANVISA, South Korea, Russian MoH, Isreal, Turkey to name a few. He left the company with the best Regulatory Inspection record in the history of the company.

Barry's career began in Quality Control in Biologic Drug Substance manufacturing, working for FujiFilm Diosynth BioTechnologies and its predecessor companies before moving up through the ranks of the Quality Assurance organisation to Head of Quality for the clinical facility and then Head of Operational Quality for both clinical and commercial facilities combined. In his tenure Barry supported multiple regulatory inspections including a number of product pre approval inspections from all main regulatory authorities. Barry was also responsible for providing quality oversight and licensure of FujiFilm’s first single use, multi product Mammalian Cell-Culture Facility in the UK. He also was Head of Upstream manufacturing with responsibility for safe and compliant production of cell banks and the inoculation, fermentation and separations unit operations in the manufacture of clinical and commercial microbial and mammalian cell derived biological drug substance across 6 lines.