Posted Date: Jun 21 2023
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 projects/programmes.
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.
$ads={1}
Key Responsibilities:- Implement and manage the QA audit programme for one or more clinical development projects/programmes; partner with clinical teams to ensure appropriate risk prioritisation, scheduling, and tracking of QA audits. Provide active support during root cause analysis and support CAPA development
- Implement and manage Quality Assurance Plans for all programmes where audit activities are performed.
- Generate compliance statements for the Clinical study report where audit actives have been performed as requested by the clinical teams
- Provide support to CQA RII in the co-ordination and management of Regulatory Inspection activities for applicable clinical programmes . 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. Provide support in the root cause analysis activities for any inspection findings identified and support the business in development of responses
- 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.
- Provide proactive and regular communication of trends, risk identification, analysis and performance metrics from QA audit and all investigation and inspection activities within the business function and across R&D 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 in depth 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.
Why You?
Basic Qualifications:
- Bachelor’s degree in related Health Science field or equivalent.
- Five or more years of pharmaceutical industry experience.
- Two or more years of experience in pharmaceutical research and/or pharmacovigilance.
- Two or more years of experience with Good Clinical Practice, Good Pharmacovigilance Practice and/or Quality Assurance.
Preferred Qualifications:
- 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
- A demonstrated and sound working knowledge with expert understanding of the approach and perspectives of regulatory agencies
- Demonstrated experience interacting with regulatory agencies
- The ability to function effectively and strategically as team member; to communicate professionally and effectively, with all levels of management and to negotiate persuasively
- Must have a high degree of organizational awareness and working towards resolution with complex problems
- Have demonstrated project management skills, prioritisation and management of cross-functional activities
- Have demonstrated ability for excellent verbal, written and presentation skills
Why GSK?
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
LI-GSK
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.
