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As an External Quality Drug Product Lead, you will be reporting to the Specialty External Manufacturing Quality Director or deputy 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, these responsibilities include some of the following:
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
We are looking for professionals with these required skills to achieve our goals:
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.
If you have the following characteristics, it would be a plus:
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.
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - usrecruitment.adjustments@gsk.com
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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