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Biopharm QA Manager
Location:
King Of Prussia, PA
Description:
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 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 an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-XXXX (US Toll Free) or +1 801 567 XXXX (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. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.PDN-9c5235c2-e736-4702-9717-6acaf3d7313b
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More About this Listing: Biopharm QA Manager
Biopharm QA Manager is a Quality Assurance QA Manager Job at GSK located in King Of Prussia PA. Find other listings like Biopharm QA Manager by searching Oodle for Quality Assurance QA Manager Jobs.
Biopharm QA Manager is a Quality Assurance QA Manager Job at GSK located in King Of Prussia PA. Find other listings like Biopharm QA Manager by searching Oodle for Quality Assurance QA Manager Jobs.