Business Process Quality Lead/associate Director:
il y a 3 semaines
**Site Name**: UK - London - Brentford, Belgium-Wavre, UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper Providence
**Posted Date**: Feb 17 2023
**Business Process Quality Lead/Associate Director**
We’re combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated.
In 2021 we delivered four major product approvals: Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude, our new long-acting medicine for HIV prevention.
Find out more:
Our approach to R&D
In this role you will deliver independent quality oversight to GSK R&D as valued partner and act as single point of accountability for one or more assigned processes that describe GCP and Human Subject Research activities.
Ensure written standards governing Human Subject Research regulated activities comply with applicable regulatory requirements and the GSK Quality Standards.
Ensure assessment of system validation requirements are conducted for associated computer systems.
Build and maintain partnerships with the Global Process Owners (GPO), Business System Owners (BSO) and Computer Systems Quality Assurance (CSQA).
Develop, maintain and deliver GCP training.
**Key Responsibilities**:
- Single point accountability for proactive quality input to GCP regulated processes or IT system development. Providing input and interpretation of regulatory requirements, inspection and audit findings, CAPAs, external initiatives, and GSK expectations
- Ensure GCP procedures are compliant with regulatory requirements as well as new and revised GSK standards and policies in the area of clinical development; acting as the first line contact for questions around these.
- Collaborate effectively within GQA, specifically with Written Standards and Learning, to ensure CQA input to and review of written standards covering GCP/Human Subject Research regulated activities including change control
- Conduct the review of specific documents related to validation of GCP Clinical IT Systems to assure compliance with regulatory requirements and GSK standards (i.e. User Requirements Specification, Process Map, GxP Risk Assessment)
- Drive, coordinate and manage the development of GCP training initiatives. Ensure quality input and oversight on GCP training material and ensures that training strategy complies with GCP and regulatory requirements. Deliver GCP training as part of the GCP training strategy.
- Establish strong working relationships with a network of contacts including Global Process Owners, Internal Control Framework Excellence, Risk Managers, clinical project team members and business function leaders
- Manage interface and collaborate effectively within GQA, specifically with Written Standards and Learning and Computer System QA to drive alignment and harmonization of related processes
- 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.
- Maintain an up to date and in depth knowledge of appropriate national and international GCP legislation, regulation and guidelines. Lead the interpretation of changes, assessing the impact to assigned business area processes and procedures
- Maintain awareness of and proactively analyse audit, inspection and investigation outcomes to ensure these are translated into business process improvement and GCP training initiatives
- Coordinate, manage and/or lead investigations of significant quality issues, 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.
- Partner with clinical teams and/or relevant stakeholders to ensure appropriate risk prioritisation, scheduling, and tracking of QA process audits. Provide active support during root cause analysis and support CAPA development
- Deputise for Head, Internal Process Programme Management, CQA and take on delegated duties as required.
**_ Closing Date for Applications: 01/03/2023_**:
Please take a copy of the Job Description, as this will not be available post closure of the advert.- LI-GSK
**_ Why you?_**:
**Qualifications & Skills**:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor’s degree in related Health Science field or equivalent
- A broad scientific/pharmaceutical industry background with relevant experience in pharmaceutical research and/or pharmacovigilance
- Previous e
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