Site Name: USA - Pennsylvania - King of Prussia, Belgium-Wavre, UK - Hertfordshire - Ware
Posted Date: Dec 18 2024
The Analytical Lead manages the analytical aspects of the product lifecycle, collaborating with external supply quality, R&D, MSAT, the rest of Global QC, and all manufacturing sites. This role is accountable for supporting difficult analytical investigations, is the SPOC for LICs and PIRCs, and provides support during audits.
In addition, the role is accountable for identifying special new platform/trends requirements in the analytical area.
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 functions involved in the analytical space.
* Act as SPOC for LICs, PIRCs, and difficult investigations.
* Provide support to sites during audits.
* Identify special and new platforms/trends requirements in the analytical area.
* Provide SME support for analytical transfer, methods troubleshooting, specs settings, and analytical methods definition.
* In partnership with R&D, Quality Leaders, and MSAT, ensure new products or changes to legacy products are done in compliance with the most updated requirements, including expectations for PAT, RTR, and new analytical platforms introductions in line with GSK innovation and sustainability objectives.
* In specific cases, write or review dossier filing and HAQs.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
* Bachelor’s Degree.
* 7+ years’ experience in the Quality function in a highly regulated environment.
* 3+ years of lab or QA experience.
* Experience in Vaccines analytical testing area.
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
* Master’s degree or PhD.
* Demonstrated leadership skills across functions and organizational levels.
* Knowledge of QC analytical methods and manufacturing processes.
* Competence in problem-solving.
* Demonstrated leadership and networking skills across sites.
* 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 site levels.
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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 organization 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.
If you require accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status, or any other federal, state, or local protected class.
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