Quality Computer System Validation Senior Lead

Overview

GSK are looking for a Quality and Computer Systems Validation (CSV) Manager to join them on a full-time and permanent basis. This is a strategic and global role, highly visible with a diverse mix of stakeholders across multiple functions. Given our hybrid working model, there is flexibility in the location. 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.

Responsibilities

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. Actively manage risks through problem solving and clearly planned mitigations.

Proven ability to organize and manage the validation, deployment, change management of large, complex, computerized 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 and validation principles and activities.

Qualifications

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

Company and BenefitsGSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we\''re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. 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.

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 consider the CMS Open Payments website for open data.

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 practices; 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 | ..... full job details .....