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.
• 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.

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.
• 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.
• 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.

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.
• 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.
• 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.

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.

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.

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.

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.

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.

• 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.
• 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.

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.

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