QC Analytical Methods Lifecycle Lead

QC Analytical Methods Lifecycle Lead Manages the analytical aspects of product lifecycle collaborating with external supply quality, R&D, MSAT, the rest of Global QC and all Vx manufacturing sites. This role consists in supporting difficult analytical investigation, LICs and PIRCs, review analytical submissions source documents and support to audits.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Provide SME support to methods lifecycle issues collaborating with all the functions involved in analytical space
• Provide Quality oversight in QC Methods robustness for NPI and Lifecycle products
• Support LICs, PIRCs and difficult investigations
• Provide support to sites during audits
• Provide SME support for analytical transfer, methods troubleshooting, specs settings and analytical methods definition, submission files
• In specific cases write or review dossier filing and HAQs

Basic qualifications:

• Masters degree in Chemistry, Microbiology, Biological Sciences, Analytical Science, Pharmaceutical Sciences, bio or Chemical Engineering
• 5+ years of experience in Quality function or managing Quality Related activities in pharmaceutical industry with quality control experience.

Preferred Qualifications:

• Demonstrated knowledge of QC environment with extensive knowledge of GMPs, and of quality and regulatory compliance requirements. Familiarity with FDA/EU/ICH regulations and guidance, particularly as they relate to Analytical Testing.

• Applies technical knowledge to provide DMAIC support

• Excellent written/verbal communication, presentation and effective influencing skills, with the ability to make persuasive recommendations based on rational technical analysis.

• Strong leader in communication and influencing at key stakeholders and sites level

#LI-GSK

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.

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