Clinical Trials

Provide operational management and technical support to insourced laboratory Synergy teams across the UK. & overseas to ensure delivery against contractual SLAs/KPIs is achieved to the highest quality standards. In addition to operational management a key element of the role is to support new business, account development and bid defense opportunities.

Responsible for leading the Quality Assurance and Quality Control Teams. Driving implementation and delivery of the site compliance remediation plan including improvement of the all QMS, support continuous improvement projects and ensure safe products to Catalent's clients. Hosting FDA, MHRA, UK Food Agency and MoiT inspections.

Responsible for setting up, implementing and maintaining the quality system for the British Isles and Ireland commercial affiliate that supports compliance with pharmaceutical regulatory requirements. Assuring that the importation, receipt, distribution, and where relevant contract and licensing manufacturing operations, comply with relevant UCB policies, with Good Manufacturing & Distribution Practices and with local regulatory requirements. Provided QA expertise for the consolidated supply chain to ensure Marketed Products are controlled in accordance with 2001/83/EC, and 2003/94/EC and other applicable regulatory requirements and effectively partnering with Supply Chain Operations and Commercial groups, Project Teams, other Global and Operational Quality Assurance teams. Main technical expert in the manufacture and testing of Pharmaceutical Product for the local Affiliate and QA contact with the MHRA and HPRA for activities related to product investigations. Managed a team of 3 direct reports including the EU Qualified Person

I was managing the completion of various on-going Product technology transfer projects and supporting the local implementation of the new Corporate ABPI compliance process. I was also transitioning from the BII Commercial Team to the BII Quality Assurance Team. As part of that transition I have been leading various activities in relation with the latest GMP updates such as performing a gap analysis of the current Pharmaceutical Quality System and taking actions to improve the system in the most simple and efficient way (e.g. updating our technical agreement template to ensure that UCB contractors meet the latest GMP requirements, updating, writing, withdrawing or merging some of the local SOPs). I have also started, in June 2014, training to become an EU Qualified Person.

I was responsible for the management of Product technology transfers including analytical and manufacturing processes of key Commercial Products (PFS, capsules and tablets) between the UCB UK Affiliate and European Contract Manufacturing organisations. I managed all aspects of the technology transfers including the business case assessment, vendor selection, Product File, project planning, execution and delivery. In this role I was the key operational contact between the various internal and external stakeholders.

I was responsible to identify, assess and mitigate cGMP risks as part of the Corporate QA Risk Management Committee in collaboration with the QA Heads of the various cGMP areas. I was responsible to ensure alignment at the corporate level between Quality and Technical Operations Risk Management databases. I led the Improvement Project Portfolio for the Corporate Product Supply QA department.

I have mainly worked on projects from product and vendor management perspectives. I successfully led the implementation of a corporate compliance dashboard across UCB QA manufacturing site and Corporate QA. In collaboration with Global Business key stakeholders I was responsible for the implementation of a corporate vendor database, a corporate and cross-functional vendor management Quality System, and a vendor risk assessment process and associated tools. I played a key role in the implementation and maintenance of the global functional SOPs to support strategically important Products and Vendors and vendor monitoring tools. On a day to day basis my role was to manage Contract Manufacturing Organisation activities related to the cGMP manufacture of pharmaceutical products according to regulatory dossier and coordinate the related activities between the related UCB manufacturing sites.

I was responsible for the day to day Quality Management of CMOs and in-license partners located in US and Emerging Markets in partnership with other Quality entities, Legal, Business Development, Supply Chain, Purchasing and Manufacturing Global department. I audited key vendors for the manufacture of UCB Global Products and implemented quality agreements with key CMOs and vendors. I also provided support during cGMP regulatory inspections.

My responsibilities were to coordinate within UCB and with the Contract Manufacturing Organization, all development activities from phase II to commercial of the manufacture of drug substance (biologics) in the Good Manufacturing Practices regulated environment. I coordinated all activities for assigned projects and driven internal and external project delivery. I was the author of various development and validation documents to support New Drug Application file.

Management of the Quality Assurance and Quality Control activities of the microbiological production laboratory managing and developing a team of three staff. Management, planning, technology watch and process engineering of molecular biological and microbiological screenings. Key member of the Quality Steering Committee leading the implementation, completion and successful certification of the ISO 9001 quality system. Actively engaged in the development of the company Industrial Operation strategy.