Associate Director, Third-party Programme
il y a 1 semaine
Site Name:
Belgium-Wavre, Durham Blackwell Street, Stevenage
Posted Date:
May 3 2023
About the role:
As a Associate Director, Third-Party Programme Management, CQA, you will be expected to deliver independent quality oversight and management to GSK R&D as a valued partner acting as the single point of accountability for one or more clinical development Third-Party Providers; and ensure delivery of an effective independent audit programme that provides assurance that clinical trial activities governed by GCP and related regulations undertaken by and/or on behalf of GSK are compliant with relevant international regulatory agency regulations / guidelines, GSK policies / procedures, and are conducted in accordance with accepted principles for clinical trial research.
What will be some of your responsibilities?:
- Implement and manage the QA audit programme for one or more Third-
Party Providers:
develop and maintain the in-scope audit universe and propose a fit-for-purpose and risk-based strategy for the yearly audit planning, in accordance with needs and requirements of clinical teams, partner with clinical teams and/or relevant stakeholders to ensure appropriate risk prioritisation, scheduling, and tracking of QA audits.
Provide active support during root cause analysis and support CAPA development- Lead the negotiation, review and implementation of Quality Clauses/Agreements in partnership with clinical teams and Third-Party Provider stakeholders
- Act as GCP SME for Risk Due Diligence and Technical Qualification of Third-Party Providers.
- Generate compliance statements for the Clinical study report where audit activities have been performed as requested by the clinical teams
- Provide support to CQA RII in the coordination and management of Regulatory Inspection activities related to Third-Party Providers. Serve as the main point of contact for inspection preparation partnering with risk managers to ensure business function is prepared for both national and local inspections (FDA, EMA, MHRA, etc.). Ensure identification and mitigation of known quality issues and potential GCP compliance risks impacting Third-Party Providers. Provide support in the root cause analysis activities for inspection findings identified impacting Third-Party Providers and support the business in development of responses
- Coordinate, manage and/or lead investigations of significant quality issues impacting Third-Party Providers, support root cause analysis activities and ensure subsequent corrective and preventative actions provide necessary remediation. Ensure appropriate escalation as per GSK global policies and processes.
- Provide proactive and regular oversight and communication of trends, risk identification, analysis and performance metrics from QA audit and all investigation and inspection activities within the business function, across R&D and with the Thirdparty Provider to ensure effective implementation of controls, management monitoring and independent business monitoring
- Establish strong working relationships with a network of contacts including clinical project team members, business function leaders, Risk Managers and Ethics & Compliance Officers
- Maintain an up to date and indepth knowledge of appropriate national and international GCP legislation, regulation and guidelines; and the impact to assigned business area processes and procedures
- Educate, guide and influence GSK management and staff on best quality and compliance policy and practices, especially as they relate to areas of identified responsibility.
- Support local and international GxP and process improvement projects by providing CQA input, especially on areas of responsibility and/or expertise. Assist business Capability Groups in developing and maintaining customer training programmes and help deliver training within area of expertise
- Deputize for Head, Third Party Programme Management, CQA and take on delegated duties as required
_ Why you?_:
Basic Qualifications**:
- Bachelor's degree in related Health Science field or equivalent
- Broad scientific/pharmaceutical industry background with relevant experience in pharmaceutical research and/or pharmacovigilance
- Previous experience of Good Clinical Practice, Good Pharmacovigilance Practice and/or Quality Assurance
- Extensive knowledge of global, regional and national regulatory requirements and regulations
- Detailed knowledge of the drug development and clinical processes
- Demonstrated ability to manage global projects and programs, which can contain regional focus/drivers in a culturally diverse organization
- Demonstrated and sound working knowledge with expert understanding of the approach and perspectives of regulatory agencies
- Demonstrated experience interacting with regulatory agencies
- Ability to function effectively and strategically as team member; to communicate professionally and effectively, with all levels of management and to negotiate persuasi
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