Quality and Computer Systems Validation (CSV) Manager

GSK are looking for a Quality and Computer Systems Validation (CSV) Manager to join them on a full-time and permanent basis.

This is strategic and global role, which is highly visible where you will be dealing with diverse mix of stakeholders across multiple functions.

Given our hybrid working model, there is flexibility of the location of the role.

The Quality and Computer Systems Validation Manager provides quality oversight to support implementation and maintenance of strategic computerised systems.

This is a hands-on role and responsibilities will include strategic project engagements to ensure the necessary business and quality oversight is embedded within all system life-cycle stages. You will encompass business, technical and operational change activities within projects.

The role will ensure robust, consistent processes are utilized and maintained with a focus on proactive risk management and data driven continuous improvement.,

• In collaboration with end users and Tech, develop global business processes for GxP operations that are supported by IT systems, e.g. eBRS, LES, M-ERP


• Ensure that the process and automated solutions satisfy compliance requirements and any regulatory constraints.


• Provide expert advice and support to GSC Sites on the business processes supporting the Quality IT Strategy, to achieve consistent application of business processes and systems and to share best practice.


• Use expertise and GEMBA to find ways to improve the effectiveness and efficiency of automated processes to reduce customer costs, improve the user experience and improve Quality understanding and performance. Drive these improvement activities through to business benefit delivery.


• Establish quality standards for data management including data formatting, data cleaning, standardization and analysis and educate users in these standards. Work with IT teams and GSC to enforce the standards.


• Ensure robust pro-active risk management processes are in-use and that risks are clearly defined and communicated to stakeholders. Will actively manage risks through problem solving and clearly planned mitigations., 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 .

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 .

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• Proven ability to organize and manage the validation, deployment, change management of large, complex, computerised systems, people and tasks based at multiple locations globally, prioritizing conflicting demands in a measured, business focused way.


• Understanding of pharmaceutical manufacturing, laboratory and distribution regulations, guidelines, principles and expectations with proven ability to interpret and apply company guidelines, principles and expectations.


• Ability to analyze complex data/information/scenarios and make rational, risk based decisions which are communicated and/or escalated clearly and confidently. Addresses challenges to Quality and compliance decisions/positions in a knowledgeable and assertive manner.


• Proven ability 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.


• Proven ability to manage teams assigned to projects and experience in coaching/mentoring various personnel in quality & validation principles and activities.


Preferred Qualifications & Skills:

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

• B.S. or advanced degree in Computer Science, Engineering, Pharmacology or related sciences


• Excellent interpersonal skills, including the ability to work across the organization and interact/influence/negotiate effectively at all levels of management and peers.


• Ability to work well under pressure with tight timelines


• Excellent consultative, listening, communications and analytical skills


• Must be flexible, adaptable and a strong team player


• Negotiation and conflict resolutions skills


• Coaching and involving team members to understand the need for improvement and encouraging contribution of ideas
  
  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.

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