GlaxoSmithKline
Job title:
GBPO Audit
Company
GlaxoSmithKline
Job description
Location: WavreOther locations may be envisaged (close to a GSK site)Job PurposeAs an enterprise level Global Business Process Owner, you will be responsible for creating the strategy and process for global quality audits that are both compliant with current GMP requirements and expectations and driven by the principles of continuous improvement.You will review data from systems and users to diagnose where change is needed and, where appropriate, implement cross functional organisational change projects which improve business performance.You will also provide governance of operational area leads (GSK Sites, LOC, Warehousing, Distribution Centres) compliance with Good Manufacturing Practices (GMP), by trending the key performance indicator for your process.Key ResponsibilitiesDrive standardization, innovation, and compliance for the end to end (E2E) quality audit process across the networkResponsible for the process policy and GSOP, application, data and digital solutions associated with the quality audit process.Lead/facilitate the global quality audit community of practice (CoP) across the networkAs needed, provide subject matter expertise and support to sites and functions in the context of audits or regulatory inspectionsRepresent 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/LOCsRemaining current regarding relevant global regulations and guidance, global regulatory and pharmacopeial expectations, inspection intelligence, innovative/new technologies, and industry standardsWhere changes are made to the global quality audit process, 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 network.Develop the key performance indicators, global data review and trending of the KPI providing a mechanism for oversight of the effectiveness and level of conformance to the global quality audit process.Knowledge/ Education / Experience RequiredEducational BackgroundMinimum Level of EducationMinimum Bachelor Degree in scientific or engineering discipline, or able to demonstrate equivalent level of knowledgePreferred Level of EducationMaster of Science or PhD in scientific or engineering discipline, or able to demonstrate equivalent level of knowledge.Job-Related ExperienceMinimum Level of Job-Related Experience required:Minimum of 10 years of pharmaceutical/ vaccines manufacture, release & distribution.Good understanding of ICH Q10 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, and industry standardsGSK certified auditor or accreditation from external quality or regulatory professional organization (i.e. Regulatory Affairs Professional Society Certification (RAC), ASQ Quality Auditor Certification) or equivalent industry experience.Other Job-Related Skills/BackgroundExcellent written and verbal communication skills. The role will require working across many different cultures, functions and manufacturing/ distribution operational areas, therefore a good span of knowledge would be advantageous.When applying for this role, please download your CV in English + a cover letter to describe how you meet the competencies for this role.#LI-GSK# LI-HybridIf you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.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.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.
Expected salary
Location
Waver, Waals Brabant
Job date
Tue, 25 Jun 2024 02:05:41 GMT
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