Job Description

Site Name: UK - Hertfordshire - Stevenage
Posted Date: Nov 28 2023
The role of Associate Director, Precision Medicine Quality & Design, will be to support the development and validation of biomarker assays and Precision Medicine Solutions. In addition, they will be responsible for supporting the Head of Precision Medicine Quality & Design in the development of a systematic quality risk management program for Precision Medicine (PM) across multiple areas, including \xe2\x80\x9cfit-for-purpose\xe2\x80\x9d assay validation, regulatory risk, human biological samples, data disclosure, anti-bribery and corruption, privacy and most importantly, GCP. The Associate Director PM Quality & Design will ensure Precision Medicine strategies on and operations within programs they support are compliant with GSK policies and procedures and regulatory requirements. The role covers a wide scope of operational quality and compliance responsibilities, from Ph1 through to launch. As Associate Director, Precision Medicine Quality & Design, you will work effectively in a matrix across PM business functions to ensure that quality and compliance requirements are clearly identified and understood, risks are proactively managed and mitigated, and best practices established. You will partner with the business to identify and manage inherent and emerging PM risks which individually or collectively influence the achievement of our strategic goals and protect our license to operate. 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 | GSK In this role you will

• Provide the required expertise in the delivery of operational quality and risk management, leading through matrix teams across PM.
• Support the development and validation of biomarker assays and Precision Medicine Solutions.
• Facilitate/participate in projects to deliver improvements to the clinical laboratory Quality Management System through collaboration with R&D
• Understand the business needs of PM departments, with respect to technology infrastructure, third party work and human biological sample management by developing strong working relationships in order to develop best practices and complaint processes to ensure Regulatory Compliance and maximize the business impact of investments in PM for pipeline impact and technology innovation.
• Author and review PM written standard proposals and written standards which have PM scope, as required. Facilitate applicable training and development programs.
• Serve as a contact during regulatory inspections. Lead and participate in internal/external audits and facilitate responses to audit findings. Ensure that deficiencies are addressed, and learning is shared.

Why you? Basic Qualifications & Skills: We are looking for professionals with these required skills to achieve our goals:

• Bachelor\xe2\x80\x99s degree
• Extensive R&D experience including experience in clinical development.
• Understanding of drug development and approval process and life cycle management
• Broad knowledge of technical platforms that include IHC, immunoassay, PCR, NGS and novel assay technologies (digital pathology, liquid biopsy, multiplex technologies)
• Experience in performing due diligence and auditing vendors for CDx test placement. Understanding of GCP/GCLP, CLIA, CAP, ISO15189 laboratory requirements
• Experience in CLSI, NYDOH and other industry standards for assay validation; Understanding of IVD regulations including QSR regulations, GMP manufacturing, ISO13485, and FDA and EU medical device regulations.

Preferred Qualifications & Skills: Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

• Master\xe2\x80\x99s degree
• Attention to detail with excellent planning, time management and organizational skills.
• Experience demonstrating knowledge of essential regulatory guidelines world-wide.
• Awareness of or experience in clinical space in a pharmaceutical or biotech R&D environment or leading academic research center.
• Strong written/verbal communication skills and the demonstrated ability to work in a matrix and effectively collaborate with internal and external groups.
• Capability to lead and navigate complex projects, coordinate demands and timelines, influence stakeholders, manage expectations and align project strategies among stakeholders.

Closing Date for Applications \xe2\x80\x93 15th December 2023 (COB) Please take a copy of the , as this will not be available post closure of the advert.
When applying for this role, please use the \xe2\x80\x98cover letter\xe2\x80\x99 of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application. Why Us? GSK is a global biopharma company with a special purpose \xe2\x80\x93 to unite science, technology and talent to get ahead of disease together \xe2\x80\x93 so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns \xe2\x80\x93 as an organization 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\xe2\x80\x99s 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\xe2\x80\x99re 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. 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 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/ 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\xe2\x80\x99s compliance to all federal and state US Transparency requirements. For more information, please visit GSK\xe2\x80\x99s Transparency Reporting For the Record site.