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 (R&D 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 R&D 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:
1. Strategically oversee the operation and continuous improvement of the R&D QMS, ensuring it not only aligns with but also actively supports and enhances the overarching R&D strategy and vision.
2. Proactively ensure the R&D QMS anticipates and adapts to evolving regulatory landscapes, fostering a forward-looking compliance culture.
3. 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 R&D.
4. Provide strategic leadership to R&D GPOs, embedding a culture of quality across R&D through integrated use of the R&D QMS, with a focus on continuous improvement, new initiatives, and strategic training development.
5. Lead the integration of digital innovation within the QMS framework to enhance accessibility, user engagement, and relevance of QMS content, aligning with R&D’s digital transformation goals.
6. Strategically manage the periodic review of the QMS, ensuring not just operational effectiveness but also alignment with the long-term strategic objectives of R&D.
7. Champion and drive a strategic quality culture transformation across R&D, 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:
1. A Bachelor's degree.
2. Experience of delivering large scale, complex IT and Business Transformation programs, working with different methodologies as needed.
3. Experience operating and maintaining Quality Management System.
4. Deep understanding of R&D and proven ability to implement major changes that affect regulated projects.
5. Ability to influence and negotiate at various levels internal and external to GSK.
6. Proven ability to lead in a matrix role through empowerment.
7. Demonstrated effective interpersonal, communications and negotiation skills for a wide variety of audiences, including senior management.
8. Problem solver, innovative, creative with operational delivery solutions.
Preferred Qualifications:
If you have the following experience, it would be a plus:
1. Advanced degrees are preferred.
2. Experience in Quality Management Systems (QMS) within the pharmaceutical, biotechnology, or related industries.
3. Proven experience in overseeing and maintaining QMS, particularly in an R&D environment.
4. Deep understanding of global regulatory requirements and expectations relevant to R&D, including FDA, EMA, and ICH guidelines.
5. Experience in ensuring compliance with regulatory standards.
6. Strong analytical skills to evaluate QMS performance and identify areas for improvement.
7. Proven ability to lead cross-functional teams to drive quality initiatives and embed quality culture.
8. 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.
Closing Date: 13th November 2024
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