Global Regulatory Compliance Senior Director

Site Name: Wavre, Barnard Castle, France

• Evreux, GSK HQ, Upper Merion, Upper Providence, USA - Maryland

• Rockville, Ware, Zebulon

Posted Date: Jun 25 2024

Please note this role can be based in US/EU or UK.

The Global Regulatory Compliance Senior Director is responsible for collaborating with Global Regulatory Affairs to establish business processes for end-to-end GxP regulatory compliance across the Medicines and Vaccines Global Supply Chain to increase quality culture and performance in alignment with regulatory authority expectations This is a highly complex role that works within a large and sophisticated network and requires being comfortable engaging senior stakeholders across the business.

Key Responsibilities

• Drive standardization, simplification, innovation, and compliance for end-to-end GxP regulatory business processes across the Medicines and Vaccines network via digital tools

• Lead/provide expertise support on regulatory elements of quality (e.g., inspections preparation and response writing, risks, observations, deviations, improvement initiatives, remediation, CAPA globalization, Quality Alerts)

• Lead/facilitate regulatory compliance governance and standardization fora, including chairing and developing annual objectives for the Regulatory Conformance Community of Practice (CoP) Steering Team, overseeing the Regulatory Conformance CoP, and contributing to the GSK CMC Oversight Team to ensure GSC needs are addressed

• Drive site capability for regulatory conformance and instill knowledge of global regulations/guidance across the network: serve as business owner for training curricula, share best practices, define implementation plans for regulatory business processes, tackle barriers to successful implementation at sites/external supply/LOCs

• Define deployment strategy within GSC for regulatory business processes and major regulatory compliance programs in GSC (e.g., endorsement at QMS Tier 1, ICH Q12, ICH M4Q, significant changes in local regulatory legislation)

• Drive/enable adoption of QMS by GRA for GxP processes in a phase-appropriate manner

• Develop, monitor, and trend key performance indicators for regulatory business processes

• Facilitate development and optimization of workflows and and management of records within Veeva as required to facilitate regulatory conformance (e.g., regulatory impacting change controls, active dossier)

• Escalate issues and risks related to business performance and/or support for regulatory compliance

• Establish governance and processes to facilitate data integrity of marketing applications

Knowledge/ Education / Experience Required

A. Educational Background

Minimum Bachelor Degree in scientific or engineering discipline, or able to demonstrate equivalent level of knowledge. Area of Specialisation : Biological, Biochemical, Pharmacy, Chemistry or other appropriate education

Master of Science or PhD in scientific or engineering discipline, or able to demonstrate equivalent level of knowledge

B. Job-Related Experience

• Minimum of 10 years of regulatory compliance experience in pharmaceutical/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 ICH Q10 Pharmaceutical Quality Systems and and QMS

• Supervisory/managerial experience - line and/or matrix

• Experience in the design, implementation, embedding and continuous improvement

C. Other Job-Related Skills/Background

• It is desirable that the incumbent will have excellent written and verbal communication skills. The role will require working across many different cultures, functions and manufacturing/distribution operational areas; therefore a good span of knowledge would be advantageous.

• Ability to develop collaborative relationships with cross-functional teams through excellent communication and engagement skills

• Strong influencing skills at all levels of the organization, and proven ability to manage networks and build relationships across a global network.

• Strong knowledge of regulations, guidances and industry standards related to CMC processes and post-approval changes

• Flexible, proactive and strategic thinking. Passion for improvements and innovation.

• Good knowledge of Global Regulatory Affairs and GSC organizations

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

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.

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