Senior Quality Manager

At GSK, we want to supercharge our data capability to better understand our patients and accelerate our ability to discover vaccines and medicines. The Onyx Research Data Platform organization represents a major investment by GSK R&D and Digital & Tech, designed to deliver a step-change in our ability to leverage data, knowledge, and prediction to find new medicines.

We are a full-stack shop consisting of product and portfolio leadership, data engineering, infrastructure and DevOps, data / metadata / knowledge platforms, and AI/ML and analysis platforms, all geared toward:

• Building a next-generation, metadata- and automation-driven data experience for GSK's scientists, engineers, and decision-makers, increasing productivity and reducing time spent on "data mechanics."
• Providing best-in-class AI/ML and data analysis environments to accelerate our predictive capabilities and attract top-tier talent.
• Aggressively engineering our data at scale, as one unified asset, to unlock the value of our unique collection of data and predictions in real-time.

We are looking for a Senior Quality Manager who will work with the Director of Onyx Quality Management to establish quality management policy, objectives, process, and documentation through leadership of these key aspects of the Onyx QMS (Quality Management system) framework:

• Provide quality support and oversight during application development and maintenance.
• Management and monitoring of CAPAs, Risks, Exceptions, and Findings
• Support Internal / External audits - including Audit Readiness activities.
• Provide quality support and oversight during application development and maintenance.
• Support the design, implementation and maintenance of QMS operational processes and governance that are fit for purpose for the Onyx Research Data Platform, including improvements through direct oversight of the end-to-end simplification and operational performance projects and that are aligned with GSK's wider quality ecosystem.
• Support effective embedding of QMS process into Onyx's engineering ways of working that fits modern agile software engineering practice, including supporting users in the implementation of the QMS
• Build strong relationships with stakeholders within and outside of Onyx to allow for effective implementation of QMS processes and activities and ensure a single Onyx quality culture.

• Partner with Onyx team members to facilitate documentation of Onyx-specific processes (focusing on the 'how') that aligns with the requirements of the ITMS.
• Monitor deliverable quality, ensure quality standards are being met for products/ projects, programs or operations within their remit, following a risk-based approach.
• Contribute to providing Project Quality assurance oversight depending on the specific project risk profile, including specific assurance reviews as requested by stakeholders.
• Ensure Business Unit activities align with Regulatory requirements and liaise with Business Quality Groups to contribute to the overall GxP validation or Sox status of the business facing application systems or services.
• Contribute to ensuring Onyx is keeping up with relevant and applicable regulatory and legal requirements through a pro-active knowledge management program.
• Quality assurance over the system change control within the Business Unit.
• Contribute to identification and initiation of Risk mitigation projects to address significant risks impacting a business unit, using Smart Controls assessments.
• Facilitate risk identification and risk discussions within the business unit, both operational risk, product/project and strategic risk.
• Enforce compliance within Tech Policies and Standards as required within Onyx.
• Ensure emerging risks are identified and escalated appropriately and in a timely manner.
• Support Product owners in the management of their project risks, ensuring risk identification process is embedded and operational.
• Maintain and monitor a continuous training and education program to ensure ongoing awareness on new and updated Policies and Standards within Onyx.
• Contribute to ensuring Onyx is ready to host external inspections from regulatory bodies (i.e., FDA, EMEA, tax authorities) as well as other external and internal auditors.

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

• Bachelor's degree or equivalent in Engineering, Computer Science, Biological Sciences, Data Management, or related fields.
• A significant amount of job-related relevant Quality Assurance experience on software products within the healthcare sector.
• Excellent knowledge in the areas of Quality Management Systems.
• Working knowledge of maintaining and implementing risk-based quality management processes.
• Strong written and verbal communication capabilities, technical writing ability and concise language skills. Proven ability to review and assess technical information ensuring delivery of user focused, fit-for-purpose, simple content.
• Demonstrated ability to motivate and work collaboratively with a team of expert staff to deliver consistently high standards, challenge the status quo, and deliver sustainable business improvements.

If you have the following characteristics, it would be a plus:

• Master's degree or equivalent in Engineering, Computer Science, Biological Sciences, Data Management, or related fields
• Knowledge of a current/emerging regulatory and legal requirements governing software is strongly desirable.

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.

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Why Us?

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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, 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*(*US only).

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.

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