Theodora O'Brien
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Vice President, Regulatory Compliance & Quality Assurance
United Kingdom
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Vice President, Regulatory Compliance & Quality AssuranceFortreaFeb 2026 - Current (9 months)As Vice President, Regulatory Compliance & Quality Assurance at Fortrea, I serve as a strategic partner to the President of Clinical Services and a key member of the Chief Quality, Regulatory, and Sustainability Officer’s leadership team. I lead the global QA strategy, governance framework, and execution of Fortrea’s Clinical Services Quality System, ensuring alignment with corporate priorities, regulatory expectations, and industry standards across all regions.
I drive quality, inspection readiness, and regulatory compliance across Fortrea’s global clinical operations by embedding strong quality practices, fostering collaboration, and strengthening systems that support high‑integrity data and operational excellence.
K- Vice President, Global QualityPremier ResearchJan 2022 - Jan 2026 (4 years 1 month)Global Quality & Commercial Strategy Leader | Driving Innovation Through Risk-Based Quality & Compliance
As Vice President of Global Quality at Premier Research, I bring a strategic lens to quality leadership—bridging clinical rigor with commercial impact. I align quality, compliance, and operational excellence with broader business goals, helping ensure that our research not only meets regulatory standards but also supports market access, and long-term value.
My leadership spans global quality systems, governance, and audit strategy—while also partnering closely with commercial and operational teams to ensure our solutions are patient-centered, regulatory-ready, and launch-aligned. By fostering a forward-thinking "Qu - Vice President, Corporate QualityPremier ResearchJan 2022 - Oct 2024 (2 years 10 months)Provides leadership, vision, and direction for Corporate Quality at Premier Research to support the Premier Corporate Goals. This position drives and promotes Quality throughout the organization and ensures that effective processes are established, implemented, and maintained to ensure compliance with applicable laws, regulations, Standard Operating Procedures, protocols and guidelines. The Vice President works in a cohesive and collaborative manner as part of the Senior Team to ensure that Premier Research grows and continually improves in all areas of Quality.
• Develop strategic plans to ensure successful rollout of the Corporate Quality strategy, action plans and objectives.
• Conduct global risk and impact assessments of iss - Executive Director, Corporate Quality OversightPremier ResearchApr 2021 - Jan 2022 (10 months)Oversees the global operations and activities of Corporate Quality Oversight, driving the VP, Global Quality System’s (GQS) vision and direction for GQS. Monitors global compliance and ensures GQS-related activities are conducted in accordance with applicable laws, regulations, and guidelines. Guides the organization in implementing best practice quality processes and procedures and investing in new and innovative technology to meet the changing quality environment and the growing demands of regulators and clients. The Executive Director is responsible for proactively and effectively directing and managing several key teams within GQS to provide the organization and other stakeholders with continuous high-quality support, providing directio
- Senior Director, Corporate Quality OversightPremier ResearchJul 2019 - Apr 2021 (1 year 10 months)Effectively manages the Corporate Quality Oversight team within GQS in order to provide the organization and other stakeholders with continuous high quality support for any global compliance, risk mitigation and inspection activities.
Directs the Compliance and Inspection teams to ensure appropriate global risk mitigation strategies are proactively implemented to ensure subject safety and regulatory compliance.
Conducts global gap analysis to ensure business operations are aligned and compliant with upcoming updates/changes to laws and regulations.
Ensures that effective processes are established, implemented, and maintained globally to ensure that Premier Research complies with applicable laws, regulations - Director, Quality Assurance, Risk and CompliancePremier ResearchAug 2018 - Jul 2019 (1 year)Support the effective leadership and strategic direction for Quality Assurance at Premier Research.
Drive and promote a ‘Quality Ethos’ throughout the organisation - acting as the global point of contact for supporting senior leadership teams in driving cross-functional collaboration to identify, analyse and report regulatory and compliance risks, and to mitigate and manage those risks in accordance with the strategic requirements of the organization.
Ensures in conjunction VP QA that effective processes are established, implemented, and maintained to ensure compliance with applicable laws, regulations, Standard Operating Procedures, protocols and guidelines.
Actively supports the reporting on the performa - Associate Director, Risk, Process and CompliancePremier ResearchMar 2018 - Aug 2018 (6 months)Responsible for building, leading and developing the Risk, Process and Compliance department strategy for ensuring business operations are aligned and compliant with upcoming updates/changes to laws and regulations.
Act as the global point of contact for supporting senior leadership teams in driving cross-functional collaboration to identify, analyse and report regulatory and compliance risks, and to mitigate and manage those risks in accordance with the strategic requirements of the organization.
Provide Sponsor facing support to Operations by managing the review of Issue(s) and/or CAPA’s to ensure both Premier Research and the Sponsor understand their accountability and the Compliance/Regulatory Risk associated with - Senior Manager, Risk, Process and CompliancePremier ResearchMar 2017 - Feb 2018 (1 year)Act as the global point of contact for supporting leadership and driving cross-functional participation in the organisation to improve the management of business critical processes and compliance to support the maintenance and improvement of the QMS to deliver desired business objectives.
Provide process mapping and developmental guidance to operational groups and support all Managers and Sponsors with advice and guidance about the quality of clinical trials deliverables.
Conduct global gap analysis to ensure business operations are aligned and compliant with upcoming updates/changes to laws and regulations. For example; ICH GCP E6 (R2) and General Data protection Regulation.
Manage the Risk, Process and Co - Process and Compliance ManagerPremier ResearchMay 2016 - Mar 2017 (11 months)Act as the global point of contact for supporting leadership and driving cross-functional participation in the organisation to improve the management of business critical processes and compliance to support the maintenance and improvement of the QMS in order to deliver desired business objectives.
Assist with Regulatory and Sponsor audits Globally/Locally office while managing the integration/harmonisation of procedural documents both following company acquisitions and as part of company globalisation in collaboration with process owners and operational groups.
Manage the Global Quality Management System procedural documents to provide improvement in the effectiveness of SOP's and processes. Provide process mapping - Compliance SpecialistJohnson JohnsonAug 2014 - Apr 2016 (1 year 9 months)• Led EVC supplier management activities, including segmentation, risk categorization, and audits, to enhance supplier-related processes.
• Coordinated the introduction and implementation of MDD standards, ensuring alignment with revised EVC procedures and documents.
• Successfully managed internal and external audits, driving the CAPA process towards zero overdue metrics. - PCompliance CoordinatorPICS Auditing LLCOct 2013 - Aug 2014 (11 months)• Provided expert advice on operational compliance across all PICS and Companies of PICS Auditing Limited.
• Implemented and enhanced compliance audit processes, aligning with ISO standards and local legislation.
• Facilitated multidisciplinary workgroups to develop risk-specific safety and health audits and procedures. - QA Co-ordinatorPowertecnique LimitedJan 2013 - Oct 2013 (10 months)• Coordinated the development and maintenance of a formal Quality System compliant with ISO9001 standards.
• Conducted internal audits focusing on business improvements to ensure compliance with Quality Management Systems.
• Reviewed processes to implement improvements and efficiencies in systems and process control.
• Analyzed interdepartmental communication to streamline interactions between projects and service functions. - Operations Process AnalystPowertecnique LimitedJun 2012 - Dec 2012 (7 months)Review processes and activities with a view to implementing improvements and efficiencies via better systems implementation or process control.
Carry out work study and process audits with a view to streamlining interactivity between projects and services functions and ultimately how they interact within the wider company. - Recruitment consultantMatchtech GroupJun 2011 - Dec 2011 (7 months)
- Pre-assessmentSpire HealthcareJan 2004 - Jun 2011 (7 years 6 months)Assess patients prior to their admission/ Pre-operative assessment.
Education
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- QISO 13485/9001 Lead Auditor, QMS Auditor/Lead Auditor for Medical DevicesQCS InternationalJan 2014ISO 13485 with ISO 9001
- ANEBOSH Construction Certificate, Health and SafetyAstutisJan 2013 - Jan 2014 (1 year 1 month)The NEBOSH National Construction Certificate covers the main legal requirements relating to health and safety in UK construction work, identification and control of construction workplace hazards, and the practical application of this knowledge. The syllabus is mapped to the National Occupational Standards for Health and Safety, and is aimed at Supervisors, Managers and CDM co-ordinators within the construction industry who are required to ensure that activities under their control are undertaken safely.
- TInternal Auditor Course, ISO9001The British Standards InstitutionJan 2013• Guarantee continuing compliance with ISO 9001:2008 requirements
• Ensure employees have quality management responsibilities and awareness
• Manage all risks and maintain and improve a global benchmark in quality standards
• Be confident that your organisation can rely on ISO certified internal auditors
• Empower colleagues through CPD and build customer confidence. - MSc, Business and ManagementUniversity of PortsmouthJan 2010 - Jan 2012 (2 years 1 month)
- BSc Biomedical ScienceUniversity of PortsmouthJan 2005 - Jan 2009 (4 years 1 month)
- DDunottar School for GirlsDunottar School for GirlsJan 2002 - Jan 2005 (3 years 1 month)
- IInternational School of ChoueifatInternational School of ChoueifatJan 1995 - Jan 2001 (6 years 1 month)
- JIRCA Auditor training, IRCA - approved SSIP AssessorJAD AssociatesA highly intensive and focused SSIP Assessor Training Programme which concentrates on the principles and techniques that are required when carrying out assessments against The Construction (Design and Management) Regulations 2007, Stage One Core Criteria.