Site Name: UK – London – New Oxford Street, UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper Providence

Posted Date: Oct 31 2024

Director, QMS Strategy and Integration

The purpose of this role is to provide visionary leadership and strategic direction for the Research Development Quality Management System (RD QMS) at GSK. The incumbent will ensure the QMS is robust, compliant, and aligned with long-term organizational goals, fostering a culture of continuous improvement and quality excellence within the RD environment. This involves proactively adapting to global regulatory changes, collaborating across the organization to innovate and refine QMS policies, and integrating digital solutions to enhance QMS processes and accessibility.

By driving strategic quality initiatives and embedding a quality-centric mindset, the role aims to uphold GSK’s commitment to delivering high-quality, safe, and effective products through rigorous and forward-thinking quality management practices.

Key Responsibilities:

• Strategically oversee the operation and continuous improvement of the RD QMS, ensuring it not only aligns with but also actively supports and enhances the overarching RD strategy and vision.
• Proactively ensure the RD QMS anticipates and adapts to evolving regulatory landscapes, fostering a forward-looking compliance culture.
• Collaborate strategically with the One QMS Team to innovate and refine Enterprise QMS Policies, ensuring they are robust, future-ready, and tailored to the unique needs of RD.
• Provide strategic leadership to RD GPOs, embedding a culture of quality across RD through integrated use of the RD QMS, with a focus on continuous improvement, new initiatives, and strategic training development.
• Lead the integration of digital innovation within the QMS framework to enhance accessibility, user engagement, and relevance of QMS content, aligning with RD’s digital transformation goals.
• Strategically manage the periodic review of the QMS, ensuring not just operational effectiveness but also alignment with the long-term strategic objectives of RD.
• Champion and drive a strategic quality culture transformation across RD, embedding quality as a core value and strategic differentiator
  
  
  

Why you?

Basic Qualifications:

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

• A Bachelors degree
• Experience of delivering large scale, complex IT and Business Transformation programs, working with different methodologies as needed.
• Experience operating and maintaining Quality Management System.
• Deep understanding of RD and proven ability to implement major changes that affect regulated projects.
• Ability to influence and negotiate at various levels internal and external to GSK.
• Proven ability to lead in a matrix role through empowerment.
• Demonstrated effective interpersonal, communications and negotiation skills for a wide variety of audiences, including senior management.
• Problem solver, innovative, creative with operational delivery solutions
  
  
  

Preferred Qualifications:

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

• Advanced degrees are preferred.
• Experience in Quality Management Systems (QMS) within the pharmaceutical, biotechnology, or related industries.
• Proven experience in overseeing and maintaining QMS, particularly in an RD environment.
• Deep understanding of global regulatory requirements and expectations relevant to RD, including FDA, EMA, and ICH guidelines.
• Experience in ensuring compliance with regulatory standards.
• Strong analytical skills to evaluate QMS performance and identify areas for improvement.
• Proven ability to lead cross-functional teams to drive quality initiatives and embed quality culture.
• Strong partnership and collaboration skills to work effectively with stakeholders across the enterprise.
  
  
  

Interested in Joining the Team?

Please apply via our online portal providing your CV and Cover Letter.

(Please take a personal copy of the Job Description, as this will not be available online post closure of the advert)

Closing Date: 13th November 2024

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | 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 or 0808 234 4391.

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