Easter Seals Jobs

Reference #: 398567 Site Name: USA - Pennsylvania - King of Prussia Posted Date: Jun 18 2024

Are you a Manufacturing or Quality Professional looking for a challenging opportunity to work with a highly energized team across the globe?  If so, this could be a great position to explore.

As a Manager, Biopharm QA, you will be responsible for effectively managing the quality of GMP activities for contracted manufacturing sites to meet both regulatory and GSK expectations. This includes internal and external partnering to address potential issues, harmonizing the quality standards and simplifying processes while driving both compliance and efficiency.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Approve GMP documentation, including Batch Records, Standard Operating Procedures, validation documentation, change controls, and other controlled documents from business partner areas. Write Standard Operating Procedures pertaining to Quality Assurance and business partner GMP systems. Perform internal assessments to measure compliance with appropriate GSK policies and procedures. Participate in quality events, such as Quality Investigations, customer complaints and vendor complaints and make recommendations for corrective and preventative actions, and to follow up on the implementation of those recommendations. Develop and deliver GxP training to business partners. Participate in the implementation of the Quality Management System including, provide subject matter expertise and perform relevant impact assessments, attend quality council, consider quality policies as part of control document approval. Generate, review and approve batch and/or packaging record templates. Conduct review of completed batch and/or packaging records. Perform material release activities (US Only) Ensure that the third party assessments are available to support material release Generate and approve relevant release documentation Provide project support including pre approval audit activities.

Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's degree in scientific discipline 3+ years experience working to cGMPs 3+ years experience with manufacturing batch record review 3+ years experience supporting quality deviations, change controls, and quality agreements 5+ years experience in lab/manufacturing/quality in biopharm

Preferred Qualifications: If you have the following characteristics, it would be a plus: Excellent communication and engagement skills Strong partnership and collaboration skills Possess a strong quality mindset Experience using quality risk management

*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 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 organisation 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 grow ng and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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