QU Program Manager

Reference #: Site Name: USA - Pennsylvania - Marietta Posted Date: Oct 21 2024 As a QU Program Manager, you will lead the development and management of strategic areas within the Quality Unit at the Marietta Site, including but not limited to Governance, Operational Excellence, Quality Risk Management, Project Oversight, and Continuous Improvement. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Leading and ensuring GPS implementation across the Quality organization. Ensure consistency of practices and tools and perform capability assessments. Maintain overview of all projects within the Quality Unit. Assist QU PMs and individuals with PMO preparation as needed. Mentor others on project planning, including financial and resource allocations, monitoring and tracking project status. Develop and track relevant project KPIs and communicate progress, risk and issue. Risk Management champion for the Quality Unit. Lead the QU Risk meetings to identify, score and mitigate risks identified in QU. Point of contact with the Site Risk Manager. Review meeting structure within the Quality Unit and ensure appropriate governance is in place at all levels and in alignment with GSC governance structure. Write and update the Site Quality Plan. Responsible to work with Global functions and other GSK sites to ensure sharing of best practices and to maintain visibility on relevant initiatives. Partner with Quality Systems to define and deliver actions/initiatives aimed to improve Quality indicators, with focus on deviations, change controls, documentation and other key quality systems. Continuous Improvement champion for the Quality Unit. Maintain overview of all Orange Belt/CI projects within QU. Facilitate sessions to drive a culture of continuous improvement using lean tools to identify new CI projects. Why you?Basic Qualifications: Bachelor's Degree in Microbiology, Biology/Virology, Biochemistry, Chemistry, Pharmacy or relevant technical discipline 5+ years experience in Quality Assurance or Quality Control (Quality Systems, compliance, product release, auditing) within clinical or commercial organization with licensed biopharmaceutical or biological products. Preferred Qualifications: If you have the following characteristics, it would be a plus: Versed in GMP's, NIH Guidelines, FDA and other regulatory agency requirements sufficient to comply to quality operations and compliance. Prior experience with licensed biopharmaceutical or biological products. 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 practicies related to the business Strong communication and problem solving skills with a demonstrated ability to work well with and influence others without direct reporting relationships Preferred - Certification or training in quality systems or cGMP compliance by a recognized organization such as ASQ Risk Management Principles and Techniques Successful Interaction with internal and external customers, cross-functional leadership, capability to drive governance across functions and stakeholders. High learning agility and analytical skills. Flexibility, tenacity, strong logical approach to problem solving, pragmatic and results driven, can-do attitude to help the organization deliver stretch goals, structured organized excellent planner, ability to coach staff on all different levels of the Quality organization, ability to influence and get buy-in of senior management, mediate and drive critical programs forward. #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 (US Toll Free) or +(outside US). 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Created: 2024-10-30