Stephan Croft, MSc., EU/UK QP (Eligible)

PRACTICE EXPERT, QUALITY

17 years’ experience in IMP, Commercial Mfg, and Global Distribution of a range of dosage forms, leading global teams, managing pharmaceutical licenses, QM systems, site commissioning/decommissioning, validation, and remediation.

About Stephan

Stephan is a Global Quality leader in the pharmaceutical industry who has broad experience in biological, ophthalmic, sterile injectable and solid dose manufacture, packaging, and distribution. Stephan also has significant practical experience as an EU/UK 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 people and organizational management experience.

Stephan has actively maintained his Continual Professional Development record with the Royal Society of Biology on an annual basis since joining in 2007. He has been a committee member of the Pharmaceutical Quality Group (CQI Special Interest Group) for more than ten years in various roles, has successfully completed the IRCA lead auditor course and exam and has been a trainee Qualified Person sponsor for a number of candidates.

Prior to joining Dark Horse in October 2021, Stephan worked within Pfizer as the Global Transportation Leader, supporting both traditional, COVD 19 vaccine, and Gene Therapy supply chain design, qualification, and operation. Stephan was responsible for the design, build, realization, and operation of the COVID-19 vaccine logistics supply chain and Quality Management System from a Quality Operations perspective. Stephan both led and managed teams of colleagues based at global locations, supporting a 24-7 distribution model.

Furthermore, Stephan worked within Pfizer as both Director and lead QP across multiple UK and EU manufacturing licenses, performing QP certification and vendor oversight of manufacturing sites across a multitude of global locations.

Prior to this, Stephan worked for Hospira as the Regional EMEA Quality Leader. During that time, Stephan managed Quality Teams and Operations across the EMEA region. Special activities during this period included supporting the integration of the EMEA regional Quality and artwork control functions, teams, activities, and records into Pfizer, new product launch and divestment, application and retirement of manufacturing and distribution licenses, compounding facilities and country office locations 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 managed multiple packaging facility expansions, transition from paper based to electronic document control and quality management systems. He also led the harmonization of Quality Management systems between locations in the US, Ireland, and UK. Stephan worked within both individual contributary expert and people management positions with Allergan.

Stephan worked as both a QC Microbiologist and Quality Officer within Cobra Biomanufacturing. Stephan’s Quality activities supported site commissioning, technology transfer, scale up, validation, quality management systems, batch record compilation and review, leading the QC Microbiology laboratory and supporting the QC Chemistry laboratory, as required.

PAST EXPERIENCE

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: March

QUALIFICATIONS

  • Bsc Biology – First Class with Honours
  • 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

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