External Quality Drug Product Lead

GSK•Upper Providence, PA

About The Position

This role supports the Biopharm Supply Chain products that are externally manufactured and tested to ensure products comply with GSK Quality expectations, specifications and registered details. The Quality Specialist provides quality and regulatory support to ensure clinical/commercial manufacturing, new product introductions and transfers at external suppliers provide for a timely and reliable supply of quality products. This role will provide YOU the opportunity to lead key activities to progress YOUR career.

Requirements

Bachelor’s degree in pharmacy, Science, or an engineering discipline.
5+ years of Manufacturing/Quality experience in the pharmaceutical industry.
Experience with the application of Quality Systems in manufacturing, warehousing and distribution.

Nice To Haves

Master's Degree in a science-related field
Being able to communicate and engage internal and external stakeholders
Ability to work independently and prioritize workload.
Strong interpersonal skills with an ability to enable and drive change.
Problem identification and solving skills.
Experience of working with multi-functional teams.

Responsibilities

Support implementation and continuous improvement of quality processes and procedures required to ensure GMP expectations for GSK external suppliers are met.
Build & maintain trusting relationship with external partners whereby influence can be applied & accepted to assure GSK quality standards are met.
Support collection, monitoring and analysis of quality performance indicators of the External Suppliers using quality standards and tools in place to identify/escalate emerging/developing trends.
Partner with key contacts at the External Supplier to ensure relevant and applicable outcomes from quality & manufacturing systems, such as batch records, deviations investigations, Change Controls, Validations, Annual Product Reviews (APRs), and product disposition are robust to ensure product quality.
Support quality and regulatory compliance.
Support compliance with QMS and cGMP requirements of external supplier via GMP Audit process.
Supports risk identification and mitigation process of external supplier and escalate as necessary.
Engage with External Supplier key contacts to ensure relevant and applicable outcomes from quality & manufacturing systems, such as batch records, deviations investigations, Change Controls, Validations, Annual Product Reviews (APRs), and product disposition are robust to ensure product quality.
Support maintenance of Quality Agreement Part A and Bs and TTS.
Assist External Suppliers with inspection preparedness planning including identification and development of storyboards.
Report and support resolution of cGMP/Regulatory compliance issues.
Request required legal documentation such as Certificate of Pharmaceutical Products (CPP), GMP certificate, Legalized and Notarized Declarations and documents as required by for LOCs.
Build & maintain good working relationships with internal partners, through compliance with applicable SOPs, Technical Terms of Supply and Service Level Agreement as applicable.
Seek clarification on Roles and Responsibilities to ensure team alignment.
Complete role-based training as assigned.
Communicate on an ongoing basis with the Quality Managers/Directors to ensure that potential quality issues are identified and that the support is provided to resolve with appropriate sense of urgency.