GSK
Validation Leader
GSK, Durham, North Carolina, United States, 27703
Validation Lead
Want to make an application Make sure your CV is up to date, then read the following job specs carefully before applying.Closing Date for Applications - 8th November (COB)(All locations advertised are included but not limited to)To provide quality oversight to support implementation and maintenance of strategic computerised systems such that they are validated and operated in accordance with company and regulatory requirements. Provide consulting and inspection support to users.We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.Discover more about our company wide benefits and life at GSK on our webpage
Life at GSK | GSKIn this role you will:Fulfil the Quality Assurance responsibilities in the preparation and approval of Computer System validation records or manage the process in accordance with relevant procedures (e.g., Quality Management System).Provide input to the validation planning of high cost, complex, strategic systems using risk-based approaches to ensure systems are fit for purpose, that significant risks are identified and mitigated, and that the approach and rigor of validation is in proportion to the risks the systems present to regulated business processes.Provide and/or facilitate quality assurance oversight for the automation of business processes related to pharmaceutical manufacture, laboratory and distribution.Identify, resolve, and avoid project problems, typically involving ongoing interaction with management teams within Tech functions, Site and Local Operating Company Quality organizations, and Third Party suppliers/service providers.Participate in the deployment, maintenance, and inspection support of multiple global projects with responsibility for developing solutions that maintain compliance and keep validation on schedule and within budget.Ensure that issues and risks are identified, mitigated, and/or escalated for matters that could adversely impact quality compliance associated with projects and systems, while providing performance measures to drive performance and continuous improvement.Why you?Qualifications & Skills:We are looking for professionals with these required skills to achieve our goals:Bachelor's degree or equivalent industry experience/subject matter expertise.Understanding of pharmaceutical manufacturing and distribution regulations, guidelines, principles and expectations.Broad experience in independently providing validation, deployment, change management, and inspection support of large, complex, computerised systems.Demonstrated ability to interpret and apply company guidelines, principles and expectations such that systems are validated in proportion to the risk they present to patient safety and product quality.Experience as an effective communicator with ability to collaborate and form strong partnerships within teams and diverse stakeholders/customers that result in "win-win" outcomes to achieve business goals and objectives.Preferred Qualifications & Skills:If you have the following characteristics, it would be a plus:B.S. or advanced degree in Computer Science, Engineering, Pharmacology or related sciences.Technical knowledge to support quality and validation decision making for GxP analytical, manufacturing, distribution and IT computerised systems.Demonstrated ability to handle multiple priorities and complete work within agreed timescales e.g. key QA role deliverables.Demonstrated ability to successfully manage support to regulatory inspections including specific queries of computer systems validation/compliance activities and documentation.Why GSK?Uniting science, technology and talent to get ahead of disease together.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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).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.As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, 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*(*US only).We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on Ukdiversity.recruitment@gsk.com or 0808 234 4391.Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive .As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.Important notice to Employment businesses/ AgenciesGSK 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.PDN-9d55b541-2e32-4964-af3b-3b92d4312633
Want to make an application Make sure your CV is up to date, then read the following job specs carefully before applying.Closing Date for Applications - 8th November (COB)(All locations advertised are included but not limited to)To provide quality oversight to support implementation and maintenance of strategic computerised systems such that they are validated and operated in accordance with company and regulatory requirements. Provide consulting and inspection support to users.We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.Discover more about our company wide benefits and life at GSK on our webpage
Life at GSK | GSKIn this role you will:Fulfil the Quality Assurance responsibilities in the preparation and approval of Computer System validation records or manage the process in accordance with relevant procedures (e.g., Quality Management System).Provide input to the validation planning of high cost, complex, strategic systems using risk-based approaches to ensure systems are fit for purpose, that significant risks are identified and mitigated, and that the approach and rigor of validation is in proportion to the risks the systems present to regulated business processes.Provide and/or facilitate quality assurance oversight for the automation of business processes related to pharmaceutical manufacture, laboratory and distribution.Identify, resolve, and avoid project problems, typically involving ongoing interaction with management teams within Tech functions, Site and Local Operating Company Quality organizations, and Third Party suppliers/service providers.Participate in the deployment, maintenance, and inspection support of multiple global projects with responsibility for developing solutions that maintain compliance and keep validation on schedule and within budget.Ensure that issues and risks are identified, mitigated, and/or escalated for matters that could adversely impact quality compliance associated with projects and systems, while providing performance measures to drive performance and continuous improvement.Why you?Qualifications & Skills:We are looking for professionals with these required skills to achieve our goals:Bachelor's degree or equivalent industry experience/subject matter expertise.Understanding of pharmaceutical manufacturing and distribution regulations, guidelines, principles and expectations.Broad experience in independently providing validation, deployment, change management, and inspection support of large, complex, computerised systems.Demonstrated ability to interpret and apply company guidelines, principles and expectations such that systems are validated in proportion to the risk they present to patient safety and product quality.Experience as an effective communicator with ability to collaborate and form strong partnerships within teams and diverse stakeholders/customers that result in "win-win" outcomes to achieve business goals and objectives.Preferred Qualifications & Skills:If you have the following characteristics, it would be a plus:B.S. or advanced degree in Computer Science, Engineering, Pharmacology or related sciences.Technical knowledge to support quality and validation decision making for GxP analytical, manufacturing, distribution and IT computerised systems.Demonstrated ability to handle multiple priorities and complete work within agreed timescales e.g. key QA role deliverables.Demonstrated ability to successfully manage support to regulatory inspections including specific queries of computer systems validation/compliance activities and documentation.Why GSK?Uniting science, technology and talent to get ahead of disease together.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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).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.As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, 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*(*US only).We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on Ukdiversity.recruitment@gsk.com or 0808 234 4391.Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive .As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.Important notice to Employment businesses/ AgenciesGSK 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.PDN-9d55b541-2e32-4964-af3b-3b92d4312633