Quality Computer System Validation Senior Lead
- London
- Permanent
- Full-time
- 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.
- 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.
- 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
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.Why GSK?
Uniting science, technology and talent to get ahead of disease together.GSK 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.Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on or 0808 234 4391. The helpline is available from 8.30am to 12.00 noon Monday to Friday, during bank holidays these times and days may vary.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 receive .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 the Centers for Medicare and Medicaid Services (CMS) website at