Manager, Computer Systems Quality Assurance Audit

Job Description Do you enjoy working with stakeholders and partners to help ensure compliance with company policies, procedures, and regulations related to computer system validation, electronic records and signatures, and data integrity? If so, this Manager, Computer Systems Quality Assurance opportunity could be an exciting opportunity to consider. Job Purpose: As a Manager, CSQA, you will participate in projects delivering computer systems within the regulated areas of Pharma R&D and Vaccines. You will conduct computer system validation related audits to ensure compliance within GSK and external to GSK. You will also support regulatory agency inspections of Pharma R&D and Vaccines to achieve successful outcomes. All of this will be done to ensure GSK R&D and Vaccines compliance and inspection readiness with respect to applicable Pharmaceutical Regulatory Agency requirements for Computerized System Validation (CSV), Regulated Electronic Records and Signatures (RERS), Regulated Electronic Data Integrity (REDI) and GSK controls. This role will have a focus on auditing and data integrity. In this role you will Provide input into the development of strategy, policy, CSQA objectives and processes in Global Quality Assurance and with business partners. Assure computer systems meet regulatory requirements and that they conform to regulatory expectations. Interact with regulators and/or industry experts to represent GSK interests. Interpret and apply regulations/policies to unique and often complex issues. Interpret and communicate changes in the regulatory environment that could impact GSK to proactively mitigate and resolve potential computer compliance issues. Proactively identify, communicate, and monitor business and/or regulatory changes that could impact on quality or compliance across Pharma R&D and Vaccines. Conduct routine computer compliance audits (internal & external) Manage computer compliance initiatives of demanding high priority including regulatory inspections and high-risk non-compliance issues (ex. lack of supporting evidence of validation). Manage CSQA priorities, schedules and/or initiatives to assure delivery of CSQA, GQA & GSK objectives. Lead CSQA initiative, program, or team activities, as required. Contribute to an environment that optimizes employee productivity and adds value. May develop group skill sets and knowledge base to meet the needs of a changing environment. Actively engage in computer compliance risk management activities to identify effective risk management strategies for identified risks. Proactively share potential computer compliance risks to the business to initiate mitigating measures. Act as coach/mentor to develop others with CSQA/GQA Represent CSQA as a primary business contact. May represent CSQA across GSK and externally Provide suitable recommendations/mutual solutions that show measurable improvement and added value to internal/external customers with respect to emerging technology as well as established solutions. Work closely with Information Technology department, system owners and business owners to effectively and efficiently implement new systems, system upgrades, or system modifications. Ability to travel up to 15% Closing Date for Applications: 13th December 22 COB Please take a copy of the Job Description, as this will not be available post closure of the advert. 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. During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process. *LI-GSK Why you? Qualifications & Skills: We are looking for professionals with these required skills to achieve our goals: University Degree in the Life Sciences or Computer Science field OR equivalent strong experience. Auditing experience Strong Computer System Validation experience– either conducting CSV or from a quality assurance perspective. High degree of organizational awareness and in-depth knowledge of the regulated pharmaceutical industry and computer compliance regulations and expectations (FDA, MHRA, etc.). Ability to understand and consider broader risks beyond pure compliance and/or cross-GxP risks. Ability to influence and negotiate at various levels internal and external to GSK. Work independently and engage with business areas in strategic and/or operational decisions on behalf of Computer Systems QA. Develop internal and/or external networks to influence key stakeholders Knowledge of Software Development Life Cycle (SDLC) principals including planning, analysis, design, development, testing, implementation, and maintenance. Preferred Qualifications & Skills: If you have the following characteristics, it would be a plus: Experience interacting with regulators either through regulatory inspections or via industry groups. Experience and practical understanding GAMP and ERES standards Understanding of cloud software (IaaS, Paas and SaaS) and associated compliance concerns. Understanding of automation and its use in computer system validation (automated testing for example) Knowledge of artificial intelligence and machine learning 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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. ‘Be You’ at GSK At GSK, we're a company with a purpose to help people do more, feel better and live longer. We realise that our purpose starts with us. When we feel at our best, we perform at our best. Therefore, we want all applicants to be able to perform their best throughout the recruitment process. We will be delighted to hear from talented individuals that align to our values. These are at the heart of everything we do and include: Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. When you set out on your adventure at GSK, we make a deal. You commit to living our values and expectations and performing against our Innovation, Performance and Trust priorities. In return, GSK commits to providing the right environment for you to thrive. Together, we build an environment where we can all thrive and focus on what matters most to each of us. As a modern employer, we empower you to be yourself, share ideas and work collaboratively Find out more: Annual Report 2021 We’re combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated. In 2021 we delivered four major product approvals: Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude, our new long-acting medicine for HIV prevention. Find out more: Our approach to R&D Hasta Odak, Şeffaflık, Saygı ve Dürüstlük değerlerimizin yönlendirdiği bir şirket olarak, katılım ve çeşitliliğin başarılı olabilmemiz için şart olduğunu biliyoruz. Tüm meslektaşlarımızın GSK'de başarılı olmalarını, kendilerini iyi hissetmelerini sağlamak ve kariyerlerini büyütmeye devam etmelerini istiyoruz. Bir rol için aday olarak aynı şekilde hissetmenizi istiyoruz. Tüm rollerimiz için çevik bir çalışma kültürüne inanıyoruz. Esneklik sizin için önemliyse, işe alım ekibimizle fırsatların neler olduğunu keşfetmenizi öneririz. Güçlü ve yeteneklerinizi göstermenize yardımcı olabilecek sürecimizle ilgili herhangi bir düzeltmeyi görüşmek isterseniz, lütfen bizimle iletişime geçmekten çekinmeyin. & Nbsp; Bizi 0808 234 4391 numaralı telefondan arayabilir veya e-posta gönderebilirsiniz [email protected]. Başvururken, sizden gönüllü olan bazı kişisel bilgileri paylaşmanızı isteyeceğiz. 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