Senior Quality Manager

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As part of GSK’s ambition to “Supercharge our data capability”, 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, Onyx Quality Management to embed the Onyx Quality Framework through the following:

·       Provide quality support and oversight during applications and data pipelines development and maintenance. 

·       Management and monitoring of issues/findings, CAPAs, risks and exceptions. 

·       Support Internal / External audits – including Audit Readiness activities 

·       Support the design, implementation and Maintenace of the Quality Framework operational processes and governance that are fit for purpose, including improvements through direct oversight of the end-to-end simplification and operational performance projects and that are aligned with GSK’s wider quality and cyber security ecosystem.

·       Support effective embedding of quality process into Onyx’s engineering ways of working that fits modern agile software engineering practice. 

·       Build strong relationships with stakeholders within and outside of Onyx to allow for effective implementation of processes building a single Onyx quality culture focused at continuous improvement.

Key responsibilities:

Governance & Compliance:

• Partner with Onyx team members to facilitate documentation of Onyx-specific processes (focusing on the ‘how’) that aligns with the requirements of the DTMS (Digital and Technology Management System)

• 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  

Risk Management 

• Contribute to identification and initiation of Risk mitigation projects to address significant risks impacting a Business unit using applicable Onyx and DTMS processes.

• 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 

• Partner with GRC and CSO teams as needed. 

Audit Support 

• 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. 

Why you?Basic Qualifications:

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

• Bachelor’s degree in Data Management, Biological science, Information security, Engineering or related fields.

• 6+ years of job-related relevant Quality Assurance experience in software products in the Life Sciences sector. 

• Knowledge in the areas of Quality Management Systems

• Experienced in maintaining and implementing risk based quality management processes 

Preferred Qualifications:

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

• 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

• Team player with demonstrated ability to motivate and work collaboratively with a team of expert staff to deliver consistently high standards.

• Flexible and adaptable according to the priorities and needs of the business

• Global perspective; cultural sensitivity 

• Ability to withstand reasonable pressure, self-motivated with sense of urgency. 

• Understands basics of or has background working with data engineering teams, GxP standards, software platforms and data privacy.

#GSKOnyx, #LI-GSK and #GSKTech1

The annual base salary for new hires in this position ranges from $116,325 to $193,875 taking into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.

Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

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.

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