Posted Date: Aug 1 2024
The Reference Material and Reagents Director is accountable for ensuring critical reagents and analytical standards are available for the GSK network. They must be of the required regulatory standards and coordination and supply to GSK sites, CMO and LOC to support end to end supply chain of products to the patient. The role will ensure long term availability and lifecycle management of reference materials for existing and new GSK products. You will ensure outsource partners are maintained, ensuring a priority service to GSK is maintained and that bulk materials are effectively supplied to the outsource partner in a timely manner, along with supporting information to maintain a secure supply of reference materials. Also, ensure GSK customer changes, risks and issues are managed and dealt with associated with the service provided from the outsource partner.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
- Accountable for creating and deploying the GSC strategy for the robust supply of reference material and critical reagents across the supply chain. The delivery of the strategy is a key business driver in the RFT delivery of products to the patient.
- Accountable for an internal team responsible for oversight of the reference material and reagent supply model.
- Work with the respective GSK Quality & Compliance groups to ensure ongoing Quality Compliance, meeting the standards expected by GSK.
- Responsible for assessing changes to reference material and reagent supply and agree when regulatory support is required.
- QMS in use and in place for the team and direct partners.
- Accountable for the review of management monitoring and self-inspection universe and schedule, ensuring it is appropriate and effective.
- Responsible for capability in DMAIC/Deviation support - ensuring rigorous RCA and effective CAPA development and tracking when issues in supply of critical reference materials and reagents.
- Responsible for effective assessment of non-GSK customers.
- Act as primary point of contact for GSK customers: response to customer queries, audit support, provision of data.
- Response to Regulatory and customer queries, LIC and PIRC support, review and update of regulatory dossiers.
- Responsible for ensuring the team utilises GSK systems and documents as required, eg. VQD, VQMS, IMMS, PIER, Empower, Jchem, LNB, Archive.
- Support to SQAC for auditing of outsource partner and their CROs.
- Overall management of the relationship between the outsource service provider and GSK sites.
- Identify and implement opportunities to strengthen and improve the outsource model.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor of Science degree in Chemistry
- 10+ years of leading and executing project level activities within R&D or GSC QC/QA units.
- 5+ years of experience in leadership experience
- 2+ years of project management and execution of strategy experience
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- Expert understanding and experience of the quality critical attributes of the various dose forms and the analytical technologies required for reference materials.
- Able to influence senior stakeholders to implement change across divisions (R&D, GSC).
- In-depth knowledge of the product development process.
- Excellent understanding of QbD (quality by design) principles and processes and keen understanding of the practicalities.
- Superior problem-solving skills, including the diagnosis of complex technical issues and development of practical solutions.
- Extensive knowledge of regulatory compliance requirements (e.g. FDA 21st Century GMPs) as they relate to analytical methods, laboratory controls and pharmaceutical quality.
- Proven track record in implementation of new standards and processes.
- Excellent understanding of regulatory processes for new registrations (BLAs, NDAs and MAAs).
- Working knowledge of the application of reference materials and associated quality processes.
- Proven ability to innovate and champion transformational change.