Quality Systems & Data Process Senior Director - Military Veterans

Site Name: GSK HQ, Durham Blackwell Street, Parma, Stevenage, Tres Cantos, Upper Providence
Posted Date: Jun 25 2024

Quality Systems and Data Process Senior Director

The role can be located anywhere in the US, Europe or UK

The deadline for the job posting is the 15th of July in 2024

We make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics. We operate at impressive scale, producing over 2.3 billion packs of medicines and doses of vaccines in 2023.

We continue to modernise, so we can launch even more new products at speed whilst continuing to deliver across our entire portfolio through our relentless focus on quality, safety, and service. The way we work will change. For some, the shift in technology and products will be revolutionary. Our R&D pipeline demands a new kind of supply chain, and we need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.

Job purpose:

The Quality Systems and Data Process Director works with the Vice President of Quality Systems and Data to transform our key quality management systems across GSK. This includes defining the strategy and roadmap for transformation and continuous improvement of relevant processes, applications, data and digital. Through effective monitoring and analysis, leading implementation of enhancements to our quality systems, strategically defining the objectives of the enterprise global process owners (change control, deviation, CAPA and GMP training), to ensure quality management maturity. By focusing on simplification, standardization and seamless user experience, this role will help to drive proactive Quality and help differentiate Quality as a competitive advantage for GSK.

Key responsibilities:

• Lead the strategy definition, deployment and performance management processes for GSK-wide change control, deviation, CAPA and GMP training. Sponsor and drive continuous improvement programs to drive standards and operational excellence of our key critical quality processes


• Accountable for ensuring robust, simplified and standardized quality processes, change management and deployment across GSK enterprise, including implementing digital and data enhancements and foundations


• Responsible for leading a team that will analyse & interpret quality system metrics and data and act on the data analytics to propose and implement process improvements and efficiencies


• Responsible for developing strong partnerships across MSAT, R&D, Engineering and Operations to ensure that compliance risks are appropriately identified, escalated, and mitigated


• Ensure the continuous alignment of, compliance to, and effectiveness of transversal processes within the QMS framework


• Responsible for managing the materials required for quality council and engaging with key stakeholders across the company to prioritize support and risk mitigation


• Accountable for the content and alignment to the legislation, supporting sites during inspections and support issue resolution. Change management and capability build of the sites and aligned SME's


• Supports and drives rapid resolution of technical issues escalated from the site-based teams or from one of the Quality groups which have a direct connection to one of our processes


• Partners with the Tech organization to define user requirements for new or existing technology solutions, ensuring complete representation of all business stakeholders


• Ensures effective data governance by applying concepts of data ownership to applicable processes and applications


• Works with Global and Regional / Local Regulatory to understand, translate and apply local regulations, being conversant with statutory obligations and GSK procedures for all regulatory requirements enterprise quality processes


• Motivate, focus and develop team, driving continuous improvement and inclusivity to ensure operational excellence

Basic Qualifications:

• BA/BS degree or equivalent in experience (Chemistry, pharmacy, biological sciences, science related)


• More than 10 years' experience in Quality function in a highly regulated environment


• Leadership, Project Management, Continuous Improvement, Decision Making, Problem Solving, and Communication


• Demonstrated experience of working at a senior level across various geographical regions and different cultures


• Experience in strategy development and deployment, change / stakeholder management and business improvement


• Demonstrated leadership skills across functions and organisational levels


• Significant experience in quality systems and QMS


• Experience in change control, deviation, CAPA and GMP training required; prior experience in global process ownership would be desirable


• Proven capacity to drive transformation and manage complex projects and program of projects. Strong in decision-making, problem-solving, and communication


• Excellent influencing and negotiating skills and verbal and written communications skills


• Demonstrated ability to operate effectively in a matrix organisation and engage with other business areas


• Demonstrated ability to think strategically and identify innovative, sustainable solutions to complex business issues


• Demonstrated people development and performance management skills


• Knowledge and experience in operational excellence / continuous improvement techniques and deployment

Preferred Qualifications:

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

• BA/BS or Masters Degree


• Strong background in QC and QA systems and/or operations


• Previous experience in global deployment of Systems


• Technical understanding of pharmaceutical manufacture and quality standards in a complex and scientific industry

LI-GSK

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.

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.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on Ukdiversity.recruitment@gsk.com or 0808 234 4391.

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 link and scroll to the Careers Section where you will find answers to multiple questions we receive .

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