Reference #: 395373 Site Name: USA - Pennsylvania - Marietta Posted Date: May 1 2024

The Quality Systems Manager is responsible for developing and administrating support systems for the production of biologics at the Marietta facility.The Quality Systems Manger is accountable for ensuring that all cGMP systems are compliant with GSK internal procedures, policies, standards, and applicable government cGMP regulations.

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

Lead the QA Systems team and ensure that all team members display a quality mindset in their performance and behaviors. Identify the strengths of each team member and ensure that each team member is a good fit for their role. Accountable for development of the QA systems team. Accountable for the management of all cGMP quality systems (includes deviations, CAPAs, change control, QMS, and others). Accountable for the management of Documentation systems (including procedures management, equipment logbooks, archival, and others). Accountable for developing and maintaining visual process maps that describe each cGMP system, the interaction between cGMP systems, and the accountabilities and responsibilities of roles in each cGMP system. Accountable for integrating cGMP system maps with the SAP business process diagrams developed and maintained by business process owners (in Operations, Quality Unit, and LTS) so that data movement, document flow, logical process flow, and workflow can be shared and communicated comprehensively (or separately, as needed) and clearly. Accountable for continuously driving improvement in business processes and business systems to improve compliance and productivity over time. Accountable for post-marketing surveillance (complaints and PQR systems and processes). Accountable for maintaining the relationships between local cGMP system owners and cGMP system owners at other sites and in global functions in order to share good practices, learning, and system issues and improvements. Accountable for leading or managing quality systems improvement and simplification projects and site initiatives as applicable. Accountable for routinely, frequently, and accurately measuring and communicating the suitability (fit for use), performance, compliance, and effectiveness of cGMP systems. Maintain all systems in a state of continuous readiness for regulatory inspections. Accountable for the Quality escalation and Quality alert processes.  Act as the site single point of contact to Regional QA for escalation events and quality alerts.  Ensure that each escalation event is closed and status is reported back to Marietta. Responsible for compliance with the GSK safety procedures and all applicable EHS regulations, standard operating procedures, and industry practices. Why you?Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals: BS or BA in a Science discipline. Minimum of 5 years' prior experience supervising quality assurance (Quality Systems, compliance, product release) within clinical or commercial organization. Supervision to include delegating, training, communicating and prioritizing site objectives, evaluating, coaching and discipling others. Minimum of 3 years' prior experience with licensed biopharmaceutical or biological products Preferred Qualifications:

If you have the following characteristics, it would be a plus: Master's degree in science or business discipline. Versed in GMP's, NIH Guidelines, FDA and other regulatory agency requirements sufficient to comply to quality operations and compliance. In-depth experience in quality systems, including validation, documentation, compliance in a high volume, rapid turnaround release office or compliance department. Strong technical understanding of industry and science practices related to the business Strong communic tion and problem solving skills with a demonstrated ability to work well with and influence others without direct reporting relationships Formal training in quality systems design or administration by a recognized industry organization such as ASQ. Lean / six sigma training (green belt, black belt, master black belt certification).

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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 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.

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