RMA Governance Specialist

GlaxoSmithKline

GlaxoSmithKline

Multiple locations
Posted on Dec 18, 2024

The Records Management and Archiving (RMA) Governance Specialist will partner with the RMA Governance Lead to manage critical governance processes including Risk Management, Management Monitoring, and Written Standards.

They will ensure that archiving training and learning content is developed and deployed to both the RMA team and R&D staff. They will engage with R&D Business Functions to support the R&D Federated Archiving Model by managing the assessments / re-assessments of Approved Archives.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

  • Manages the RMA Concerns process from initial identification of potential risks with RMA stakeholders, risk scoring and escalation (if necessary) to RMA Governance meeting.

  • Participates in the development of the Management Monitoring Universe / Plan and executes Management Monitoring assessments on RMA business activities.

  • Develops and deploys a training / learning programme for the central RMA team and the wider R&D Business Functions for both archiving principles and the eArchive system. Assists in the preparation and management of routine internal and external audits / inspections.

  • Contributes to Root Cause Analysis (RCA) and Corrective and Preventative Action (CAPA) processes as required.

  • Collates and reports the agreed KPI compliance metrics under the direction of the Director, RMA governance Lead.

  • Works with Department Archiving Leads and Functional Archivists from R&D Business Functions on the assessments / reassessments of Approved Archives in support of the Federated Archiving Model.

  • Liaises with R&D business partners to provide compliance advice/input.

  • Proactively identifies, communicates and monitors business changes that could impact on quality or compliance within RMA and across R&D.

  • Provides input and updates to the suite of Archiving written standards based updated requirements, and inputs from the Risk Management and Management Monitoring processes.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

  • Minimum bachelor’s degree in scientific or engineering discipline, or able to demonstrate equivalent level of knowledge.

  • Minimum of 5 years of pharmaceutical / vaccines practical experience directly related to governance or compliance activities.

  • Good understanding of Risk Management and Management monitoring processes.

  • Knowledge of training programmes and development of learning content.

  • Solid knowledge and experience in data analysis and visualization.

  • Experience with the use AI/ML tools for management and process improvement.

  • Independent and self-motivated

  • Results and task oriented

  • Problem/Issue resolution skills

  • Able to challenge the status quo to drive changes

Why GSK?

At GSK we offer a wide range of additional benefits:

  • Career at one of the leading global healthcare companies

  • Hybrid work ( 2/3 days per week from the office)

  • Contract of employment

  • Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)

  • Life insurance and pension plan

  • Private medical package with additional preventive healthcare services for employees and their eligible

  • Sports cards (Multisport)

  • Possibilities of development within the role and company’s structure

  • Personalized learning approach (internal trainings, mentoring, access to online training’ platforms: Keep Growing Campus, LinkedIn Learning, Business Skills, Harvard Manage Mentor, Skillsoft and external training)

  • Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities).

  • Supportive community and integration events

  • Modern office with creative rooms, fresh fruits every day

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Inclusion & Diversity at GSK:

As an employer committed to Diversity and Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.

Please contact our Recruitment Team at pl.recruitment-adjustments@gsk.com to discuss your needs.

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.

GSK is an Equal Opportunity/Affirmative Action Employer. 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.

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