GlaxoSmithKline
Job title:
Global Business Process Owner (GBPO) PQR and MAH Director, Trading Partner Quality
Company
GlaxoSmithKline
Job description
Global Business Process Owner (GBPO) PQR and MAH Director, Trading Partner QualityLocation: Dublin, Ireland or GSK HQ London, UKAs an enterprise level Global Business Process Owner, you will be responsible for forming the strategy PQR for the end-to-end process of Periodic Quality Reviews (PQR) across the supply chains. You will review data from systems and users to diagnose where change is needed and implement cross functional organisational change projects which improve business performance. In this role, you will act as the leader to collaborate with key interface partners to maintain, sustain and continuously improve process and associated tools and technologies.The role has accountability for the standardization of the procedures that continue to increase quality culture and performance in alignment with the regulatory authority expectations. You will also provide governance of operational area leads (GSK Site, External Supply Quality, LOC, Trading Partner Quality etc) compliance with Good Manufacturing Practices (GMP), by trending the key performance indicator for your process.This role will also act as the lead for the MAH team within Trading Partner Quality with the additional responsibilities as below:To ensure MAH activities undertaken by the Trading Partner entities are performed in compliance with relevant regulations, licences and authorisations.To fulfil the duties as MAH representative at inspections supporting supply to China.Ensure that PQR are performed annually for centralized products under GSK TS (and GSK Ireland until project switch has concluded).Ensure the completion of Project Switch.To ensure that Trading Partners are inspection ready and ensure the oversight and delegation for MAH duties.Key Responsibilities include, but are not limited to:Drive standardization, innovation, and compliance for end to end (E2E) process across the networkResponsible for the process policy and GSOP, application, data and digital solutions associated with the process.Lead/facilitate community of practice (CoP) across the networkSupport audit findings and preparation on topic, act as an audit coach as neededRepresent GSK in external advocacy and sharing best practices.Drive the implementation needs: training of sites, support of gap/implementation assessment, tackling barriers to successful implementation at sites/LOCsLiaise with site SMEs throughout the process: impact assessment, design, review, implementation. Responsible for ensuring the SME list is accurate.Define deployment strategy within GSK (QMS direct to LSOP or GSOP/Technical Standard) and have it endorsed at QMS Tier 1, or Quality Tier 2/3 Quality Council governance forums.Design the global standard operating procedure when required, in collaboration with One Quality QMS executive.Drive simplification of the process, design the training packs and capability across networkDevelop the key performance indicators, global data review and trending of the KPI providing a mechanism for oversight of products manufactured in multiple locations/sitesEnsure medicinal products manufactured and released within the EU where the MAH is GlaxoSmithKline (Ireland) Limited or GlaxoSmithKline Trading Services Limited are managed in accordance with EMA/419517/2021.Act as MAH representative and fulfil the duties of the MAH to support China supply whereby they use other MAH’s as a reference.Ensure the department is inspection ready with respect to the local regulatory body and that the framework of oversight is active.Maintain the contracting framework for MAH ensuring it is fully aligned to any regulatory updates as published by the EMA or local health authority.PQRsDeliver on the annual reporting and generation of PQR for centralized licences.Maintain the PQR automation system and support other functions to generate PQR for local use.Quality OrganisationLead, use and maintain the quality system within the Trading Partner organization for MAH. Ensure that the quality system complies with both GSK and external regulatory expectations.Quality Review:Accountable for the GlaxoSmithKline Trading Services Limited MAH quality council process, ensuring that quality risks, issues and metrics are discussed at a leadership team level and that appropriate actions and escalations are taken.Manage audit responses related to MAH using the relevant CAPA management databaseWhy you?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:Knowledge of global regulations and guidance, global regulatory and pharmacopeial expectations, inspection intelligence, innovative/new technologies, industry standards and registered risks pertaining to area of expertiseMinimum bachelor’s degree in scientific or engineering discipline, or able to demonstrate equivalent level of knowledgeExtensive experience in pharmaceutical/ vaccines with in-depth knowledge of PQRsGood understanding Pharmaceutical Quality SystemsGood understanding of how the topic/QMS process is implemented within global supply chain.Knowledge of global regulations and guidance, global regulatory expectations, inspection intelligence, innovative/new technologies, industry standards and registered risks pertaining to area of expertise.Preferred Qualifications:If you have the following characteristics, it would be a plus:Master of Science or PhD in scientific or engineering discipline, or able to demonstrate equivalent level of knowledgeThis role requires a deep level of GMP knowledge and problem-solving skillsAbility to deal with stakeholders across the globe: dealing with varied professional and cultural backgroundsExceptional leadership skillsExcellent oral and written communication skillsStrong interpersonal and negotiation skillsProblem identification and solving skillsAbility to enable and drive changeAble to work effectively in EnglishClosing Date for Applications: 20th November 2024 (COB)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 webpagePlease take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the ‘cover letter’ 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.#LI-HybridWhy 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 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 and scroll to the Careers Section where you will find answers to multiple questions we receiveAs 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 site.
Expected salary
Location
Dublin
Job date
Fri, 08 Nov 2024 06:54:56 GMT
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