-Masters in Biomedical & Biological Sciences, Chemistry, Biochemistry, or Pharmacy
-Regulatory Affairs experience
-Fluency in English
-7 years of experience in GMP, Quality, Operations, or Manufacturing
-Experience with third party management.
-Proficient in Italian, French, or German.
Ensure QA Oversight of third parties involved in the Clinical Manufacturing and Supplies environment
-Be the SPOC (Single Person of Contact) in the US RDC for all GMP related topics
-Be the quality contact for the group of third parties he/she is responsible for and for the internal stakeholders involved in activities contracted to these third parties
-Monitor and manage the quality performance of these third parties, and ensure they operate in compliance with GSK standards and requirements
-Organize and manage the quality governance meetings for these third parties
-Write, coordinate and ensure the follow up of the quality contracts approval and update, when necessary
-Ensure the collaboration with third parties is continuously in compliance with quality agreements and/or other relevant contracts
-Ensure complaints, deviations, change control, CAPAS, validations related to third parties are handled in a timely manner and in compliance with cGMP's and Quality Contracts
-Ensure accountability for CAPA closure for regulatory (L4) and corporate audit (L3).
-Ensure accountability for Third Parties data base (Set up, update, ...)
-Ensure Quality Systems at CMO site are regularly updated and in line with GSK QMS, through oversight and efficient analysis tool
-Be part of the third parties selection and approval process, as appropriate. Manage the approval status of these third parties
-Ensure Issues and Risks are adequately identified, analysed, assessed, mitigated and escalated
-Be involved in the third parties release certification and re-assessment process
-Review and approve all the required documentation for the batch release process, and ensure its correct archiving
-Ensure all the documentation related to these third parties is correctly reviewed, managed and archived according to GSK requirements
-Be involved in third parties audit organization, preparation and execution, as appropriate
-Be part of the transfer team for product/process transferred from GSK to a third party and from a third party to GSK
-Provide a helpful support to CMO in case of issues, in a proactive manner
-Manage its own performance and contribute to the performance of the QA TPO team in line with the lean culture principles
-Drive continuous improvement through KPI and action plans.
-Ensure SOP's and systems related to TPO management are up-to-date and compliant with the current regulatory requirements and regulations
-Represent QA TPO team at governance meetings, in delegation of the Head of TPO, when needed
You may apply for this position online by selecting the Apply now button.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK is an Equal Opportunity/Affirmative Action Employer. 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.
A little about us:
We are a science-led global healthcare company on a mission to help people to do more, feel better and live longer.