Stephan Croft, MSc., Eligible QP

Stephan is a Global Quality leader in the pharmaceutical industry who has broad experience in CGT, biological, ophthalmic, sterile injectable and solid dose manufacture, packaging, and distribution, all in support of both commercial and clinical trial models. Stephan also holds experience in cGMP manufacture, testing, and quality assurance for supply within the US, EU, and the majority of major global regulatory markets.

Stephan is an experienced Qualified Person, Responsible Person, and Manufacturers Specials Quality Controller. Having worked for both small CMO scale and large, multinational ‘blue-chip’ pharma, Stephan brings a wealth of technical and leadership experience at both ‘site’ and ‘above site’ roles.

Prior to joining Dark Horse in October 2021, Stephan worked within Pfizer and Hospira at various ‘site’ and ‘above site’ leadership and technical roles, including Global Transport Quality Leader (Vaccines, GTx and Traditional supply), EU product release leader, and Regional EMEA Quality Leader. Special activities during this period included supporting the integration of the EMEA regional integration into Pfizer, QMS and product release remediation, and large-scale remediation of a sterile injectables facility located in India and a compounding facility located within the UK.

Prior to Pfizer, Stephan worked at Allergan, supporting the manufacture and distribution of both Biologic, Ophthalmic, and a range of alternative IMP dosage forms. Stephan worked as both a Qualified Person, Responsible Person and Manufacturers Specials Quality Controller on both UK and Ireland Licenses. Stephan also worked as both a QC Microbiologist and Quality Officer within Cobra Biomanufacturing supporting a large variety of activities.

• Design and implementation of a contamination control strategy across all stages of manufacture, testing and distribution of a cell-based product within the EU for Global supply
• Leading a facility wide remediation team, including but not limited to QMS, batch release, aseptic assurance, QC laboratories, manufacturing and packaging, product release backlogs and preparing the site for inspections and application for a commercial manufacturing license
• Design, implementation and execution of inspection readiness, self-inspection, supplier audit and oversight programs. Successful preparation and application for a site manufacturing license and related inspection
• Execution of multiple successful facility, technology, and product acquisition due diligence activities
• Raw material and supply chain assurance risk assessment and management programs
• Design and implementation of both manual paper based and electronic QMS across various scales of manufacture, testing and distribution
• Organizational design, skills assessment, candidate attraction and retention programs, interim leadership, management, and coaching

• MSc. Pharmaceutical Sciences & Good Manufacturing Practice
• Royal Society of Biology – Chartered Biologist Status
• Eligible to act as a EU/UK Qualified Person, MS Specials Quality Controller & Responsible Person
• IRCA Certified Lead Auditor

Dark Horse Consulting Group
Principal
Practice Expert, Quality

Pfizer
Global Transportation Leader & Qualified Person
EU Quality Operations Director & Qualified Person supporting commercial manufacturing and supply operations

Hospira
EMEA Regional Quality Operations Director & Lead Qualified Person

Allergan
Quality Manager & Qualified Person – UK & Ireland IMP Manufacture and Supply
Senior Quality Assurance Officer

Cobra Biomanufacturing PLC
QA Officer & Microbiologist

University of Strathclyde
‍MSc. Pharmaceutical Science & GMP

University of Bedfordshire
‍BSc. (First Class/Hons) Biology