Theodora O'Brien Email & Phone Number

Morrisville, Nc, Us

Provides effective strategic and proactive leadership, vision, and direction for Global Quality at Premier Research to support the Premier Global Goals. This position drives and promotes a ‘Quality Ethos’ 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 Global Quality strategy and objectives• Provides leadership to team of Sr Director and Director-level staff, who oversee key functions within Premier Quality functions• Leads and executes a comprehensive global operational risk-based auditing strategy, focused on improving the effectiveness of risk management and governance• Responsible for the overall direction and leadership of the GQ department and ensuring the organization develop appropriate risk mitigation strategies and controls to minimize significant risk exposures• Direct Compliance and Escalations leadership team to ensure global risk and impact assessments of issues, vendors, and/or studies demonstrate compliance to pre-determined risk parameters and independence/no conflict of interest across the organization• Manage and develop the quality budget and schedules to meet corporate requirements to support the Company key objectives• Effectively manage the Global Quality Team and global audit strategy across the organization to provide continuous high-quality support to Premier Research and other Stakeholders• Provide consultancy compliance and risk management advice and training to Premier Research employees regarding quality systems, ICH guidelines, FDA regulations and other applicable regulatory standards

Morrisville, Nc, Us

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 issues, vendors, and/or studies to demonstrate compliance to pre-determined risk parameters and independence/no conflict of interest across the organization when assessing these risks.• Investigate, escalate and formally document any compliance issue which has the potential to impact subject safety, data integrity, and/or which poses potential significant regulatory or business risk. • Participate in development for Quality of corporate methods, techniques, and evaluation criteria for projects, programs, and people• Effectively manage the Global Corporate Quality Team and global audit strategy across the organization to provide continuous high-quality support to Premier Research and other Stakeholders, promote, maintain, and continually improve the global QMS• Provide consultancy compliance and risk management advice for questions and issues raised by Premier Research employees and provide training materials regarding quality systems/processes, ICH guidelines, FDA regulations and other applicable regulatory standards.

Morrisville, Nc, Us

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 direction to senior managers in various areas, groups, and/or operations. Ensures integration between GQS and other departments to produce increased productivity, efficiency, and quality. Ensures that effective processes are established, implemented, and maintained to ensure compliance with applicable laws, regulations, Standard Operating Procedures, protocols and guidelines. Educates and provides advice resulting from inspections, compliance gaps and internal audits to ensure that Premier Research continually learns and improves as an organization.• Provides executive oversight of the Corporate Quality Oversight organization to ensure quality and compliance of GQS activities consistent with relevant laws, regulations and ICH good clinical practice guidelines, the governing SOPs, and client contract. • Shapes GQS Business Development strategy in conjunction with the VP, Global Quality System’s• Responsible for identifying and evaluating fundamental issues, providing strategy and direction for GQS

Morrisville, Nc, Us

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, SOPs, protocols and guidelines, and meets Sponsor and internal requirements.

Morrisville, Nc, Us

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 performance of the QMS and any need for improvement to Senior Management Team and the wider team as appropriate.In conjunction with the VP, QA educate and provide advice resulting from audits to ensure that Premier Research continually learns and improves as an organization.Work in a cohesive and collaborate manner as part of the Premier Team to 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 potential impact, Compliance and/or Regulatory Risk associated with these gaps.Manage the QA Team effectively across the organization to provide continuous high quality support to Premier Research and other Stakeholders.

Morrisville, Nc, Us

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 these gaps.Manage billable QARC SOP writing activities, including: contracted gap analysis, process mapping, Quality Management System review and training.Provide process mapping and developmental guidance to operational groups and/or Sponsors to support the on-going quality of clinical trials deliverables.Assist with Regulatory Inspections and Sponsor audits Globally/Locally while managing the integration and harmonization of procedural documents both following company acquisitions and as part of company globalization in collaboration with process owners and operational groups.

Morrisville, Nc, Us

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 Compliance department to develop the policies, processes, procedures, systems and tools necessary to effectively identify, assess, measure, manage, mitigate, monitor and report operational and strategic risk. Assist with Regulatory and Sponsor audits Globally/Locally office while managing the integration/ harmonization of procedural documents both following company acquisitions and as part of company globalization 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.

Morrisville, Nc, Us

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 and developmental guidance to operational groups and support all Managers and Sponsors with advice and guidance about the quality of clinical trials deliverables. Conduct gap analysis and work with operational teams to support procedural document authors in document development. Ensuring feedback is sought and developed from all relevant groups. Identify solutions where process gaps and/or areas for improvement are necessary, where non-Premier SOPs are to be followed to assure compliance with GXPs, the study protocol and applicable regulations. Ensure that the systems, processes and performance of Premier Research comply with applicable laws, regulations, SOPs, protocols and guidelines, and meet Sponsor and internal requirements.

New Brunswick, Nj, Us

Lead EVC supplier management activities (segmentation, risk categorization, schedule, audit, supplier response and follow up) and liaise with other J&J sites to leverage expertise and identify opportunities for supplier related processes. Feeding back through Supplier Management within JJVC and other J&J sites.Coordinate introduction and implementation of MDD standards and align EVC procedures and documents against revised MDD Standards.Coordinate successful internal & external site audits from BSI, Visioncare Global Compliance and JJRC respectively. Drive internal Audit CAPA process towards zero overdue as per JJVC global on-time CAPA metric.Focus on CAPA Narrative and rollout baseline and progress data for; audience awareness of quality issues, likelihood of CAPA effectiveness, individual recognition of contribution to CAPA,, CAPA phase schedule adherence

Ensure the provision of professional advise and guidance with respect to operational compliance not only to the compliance department but to all PICS and Companies of PICS Auditing Limited.Implement, maintain, and enhance compliance audit processes, standards, policies and procedures within the framework of current in country legislation, ISO and Risk Specific according to the work activities and area/s to support PICS AUDITING LIMITED. Key Performance Areas• Facilitate multi disciplinary work groups to compile risk specific occupational safety and health audits, processes, standards, policies & procedures, accident/incident investigation/s.• Implement auditing, incident reporting recording & investigations .Record measurements through data analysis and business reports.• Enhance and maintain audits, systems and processes within the in country parameters of the law, best practices, ISO requirements and company objectives• Ensure the provision of professional advise and guidance with respect to operational compliance• Ensure the audits, systems, processes, standards and procedures are aligned operationally to meet business objectives and goals and where necessary design PICS specific procedures and processes.• Design and implement training sessions in order to align practices to legal and business requirements

Portsmouth, Hampshire, Gb

Co-ordinate and maintain the development and maintenance of a formal Quality System within the company, compliant with the requirements of ISO9001. Perform Internal Audits with focus on business improvements, to ensure Quality Management Systems and business processes are compliant with ISO9001.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 on interdepartmental communication, with a view to streamlining interactivity between projects and services functions and ultimately how they interact within the wider company.

Portsmouth, Hampshire, Gb

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.

Whiteley, Fareham, Gb

London, England, Gb

Assess patients prior to their admission/ Pre-operative assessment.

Internal Auditor Course, Iso9001

Iso 13485/9001 Lead Auditor, Qms Auditor/Lead Auditor For Medical Devices

Nebosh Construction Certificate, Health And Safety

Irca Auditor Training, Irca - Approved Ssip Assessor

Msc, Business And Management

2:2, Bsc Biomedical Science

Education record

Education record