Site Name: USA - California - San Francisco, Cambridge 300 Technology Square, London The Stanley Building, Poznan
Posted Date: May 3 2023

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

Are you looking for a Quality Systems Leadership role that will allow you to drive quality data transformation and set the strategic direction of data quality? If so, this Director of Onyx Quality Management could be an excellent opportunity to explore.

As the Director of Onyx Quality Management, you will work with the Head of Portfolio to establish quality management policy, objectives, process, and documentation through leadership of three key aspects of the Onyx QMS (Quality Management system) framework:

• Design and maintain sound QMS operating principles and governance for the Onyx Research Data Platform, including improvements through direct oversight of the end-to-end simplification and operational performance projects.
• Embed effective 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
• Align with wider GSK regulatory management process ensuring audit readiness/compliance.

This role is an externally credible leader who is expected to build strong relationships across tech and compliance communities and provide a strong voice for development standards and documentation across the entirety of Onyx. Partnership with Onyx program leads will be fundamental to the role to ensure we have a single Onyx Quality culture. Core Responsibilities include building and maintaining a simple, agile QMS for the Onyx Research Data Platform that is easy to understand and implement, makes compliance straightforward, and aligns with GxP requirements and GSK Digital and Tech’s ITMS where appropriate.

Key responsibilities for the Director, Onyx Quality Management include:

• 
  Defining, owning, and upholding internal Onyx QMS Operating Principles, processes, and standards to ensure the QMS remains current and compliant. Ensuring all QMS content is published, maintained and easily accessible to users.
• Developing and leading QMS change management strategies – includes building capability within the team to act as effective change agents for the QMS.
• Identifying, maintaining, and leading a network of key SMEs across key business areas to provide input to the development and review of new QMS content. Ensuring two-way communication on changes to QMS content. Identifying and establishing key stakeholder relationships across the organisation (beyond SMEs).
• Leading the maintenance and optimisation of all QMS content in alignment with key regulations, ITMS, changing legislation, business changes, internal and external intelligence, identified user/stakeholder needs and business performance opportunities. Ensuring all QMS content is aligned to the QMS operating principles and standards.
• Building and delivering robust processes to support and enable easy QMS implementation including gap analysis, impact assessment and training materials specific to Onyx.
• Maintaining audit readiness and supporting any internal or external audits.
• Promoting and monitoring deployment of the QMS aligned with a Quality mindset/culture.

Why you?

Basic Qualifications:

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

• Bachelor’s Degree in Science, Biological Science, Quality or Computer Science
• 7+ Years’ experience in Quality Systems and Quality Assurance, with an emphasis on software in a regulated industry.
• 3+ years of direct management experience
• Experience in the areas of Quality Management Systems as well as current/emerging regulatory and legal requirements governing software.

Preferred Qualifications:

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

• Master’s Degree or equivalent work experience in Biological Sciences, Computer Science, Chemistry, or related field
• Experience of product lifecycle management and software engineering within Cloud (e.g. GCP) environments
• Strong communication, 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.
• Change agent with strong leadership and managerial skills. Demonstrated ability to lead, motivate and develop a team of expert staff to deliver consistently high standards, challenge the status quo and deliver sustainable business improvements.

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigour and risk
• Managing individual and team performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Implementing change initiatives and leading change.
• Sustaining energy and well-being, building resilience in teams.
• Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
• Developing people and building a talent pipeline.
• Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
• Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
• Budgeting and forecasting, commercial and financial acumen.

#LI-GSK

#GSKOnyx

GSK offers a competitive compensation package inclusive of the following: Competitive base salary, annual bonus based on company performance, access to healthcare and wellbeing programs, retirement savings program, paid time off, and employee recognition programs which reward exceptional achievements. The salary range for this role is: $144,228 to $195,132

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 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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, 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.

Important notice to Employment businesses/ Agencies

GSK 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 GSK’s Transparency Reporting For the Record site.

GSK offers a competitive compensation package inclusive of the following: Competitive base salary, annual bonus based on company performance, access to healthcare and wellbeing programs, retirement savings program, paid time off, and employee recognition programs which reward exceptional achievements. The salary range for this role is: $144,228 to $195,132

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 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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, 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.

Important notice to Employment businesses/ Agencies

GSK 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 GSK’s Transparency Reporting For the Record site.