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Quality Regulatory Excellence Director

4 weeks ago

London, Greater London, United Kingdom GSK Full time
Job Title: Quality Regulatory Excellence Director

About the Role:

We are seeking a highly skilled Quality Regulatory Excellence Director to join our team at GSK. As a key member of our quality team, you will be responsible for delivering regulatory conformance processes and activities across our medicine and vaccines manufacturing sites and External Supply network.

Key Responsibilities:

* Serve as the accountable GSK Quality lead for regulatory conformance business processes, risk and issue management, and continuous improvement for sites, external supply, and LOCs.
* Develop and implement efficient business processes for managing regulatory information, including regulatory change control management, to support SKU management and batch release.
* Define and implement GSC strategies to meet new country requirements, such as additional testing in Korea and site data for Kenya.
* Lead regulatory conformance activities for sites and external supply to support compliance and improvement projects, including training curricula development, remediation programs, and data integrity initiatives.
* Chair the GSC Regulatory Conformance Community of Practice and Steering Team.
* Enhance site capability for regulatory conformance, disseminate knowledge of global regulations and guidance across the network, and trend key performance indicators for regulatory conformance business processes.

Requirements:

* Degree qualified in scientific or engineering discipline or able to demonstrate equivalent level of knowledge.
* Significant regulatory compliance experience in medicines/vaccines manufacture and release.
* Detailed knowledge of global regulations and guidance, global regulatory expectations, industry standards and risks pertaining to regulatory conformance processes.
* Excellent understanding of Pharmaceutical Quality Systems and QMS.
* Considerable quality experience in pharma industry or process development environment (manufacturing, quality control, quality assurance, external supply).
* Demonstrated experience managing and improving quality systems, including project management elements.
* Proven experience interfacing and influencing senior Global Leadership team stakeholders.
* Strong leadership skills.
* Ability to lead cross functional project and/or matrix teams to an aligned strategy.

Preferred Qualifications:

* BA/BS or Masters Degree.
* Excellent oral and written communication skills.
* Excellent interpersonal skills, including the ability to interact/influence/negotiate effectively at all levels of management and peers.
* Deep knowledge and experience in operational excellence / continuous improvement techniques and deployment.
* Experience and comfort working with digital systems.

About GSK:

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.

Why GSK?

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.

Equal Opportunities Employer:

GSK is an Equal Opportunity Employer. We are open to all talent. In the US, we also adhere to Affirmative Action principles.

Agile Working Culture:

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.