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Quality Assurance Systems Senior Director
Location:
Collegeville, PA
Description:
Quality Assurance Systems Senior Director The role can be located anywhere in the world The deadline for the job posting is the 15th of July in 2024 We make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics. We operate at impressive scale, producing over 2.3 billion packs of medicines and doses of vaccines in 2023. We continue to modernise, so we can launch even more new products at speed whilst continuing to deliver across our entire portfolio through our relentless focus on quality, safety, and service. The way we work will change. For some, the shift in technology and products will be revolutionary. Our R&D pipeline demands a new kind of supply chain, and we need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients. Job purpose: The QA (Quality Assurance) Systems Senior Director is accountable for leading the quality strategy for enterprise QA systems for GSK. Working as a key partner between Supply Chain Digital & Tech, quality partners, and Business Unit stakeholders to ensure robust, effective, and compliant quality systems are in place and in use. Through a defined strategy and vision, ensure our QA Systems are maintained, sustained and continuously improved to enable our vision of Quality as a competitive advantage. This includes application of effective design criteria, governance and data oversight to assure compliance, user experience and quality data. Key responsibilities: Defines the strategy and roadmap for QA Systems to align with GSK strategies, Quality Vision and Organizational priorities and goals Management of oversight of Team accountable for Business System Ownership of Enterprise QA Systems. Overall accountable for compliance, performance, strategic/capital planning, and continuous improvement of QA Systems, including the following elements: Ensures release schedules are aligned with the business priorities Executing the role of System Owner in the Data Governance framework Running System Governance/System Review Boards User management process System performance monitoring (with Tech) System investigation/CAPA (with Tech) System-level requirements/documentation, procedures and training ITMS deliverables Audit trail review Audit readiness and support (at system level) and ensures Ensures effective System-related user support model is in place (tier 3 support) Ensure the budget is managed according to GSK Finance guidelines and organizational expectations Ensure compliance with cGMP, policies and procedures as required Responsible for bringing to life the One Quality QMS vision to simplify and standardise our ways of working internally and externally. Leads Programs to deploy standard solutions and archive/decommission legacy systems (with Tech) Accountable for the Quality oversight of MES deployment, creating processes and standards for the system and participating in ongoing maintain/sustain Accountable for SAP/ERP management of Quality modules/ data, creating processes and standards for the system Accountable for Quality support of Enterprise Systems Transformation programs, as applicable, including ERP transformation Accountable for identifying and managing risks associated with enterprise QA systems Assess/ translate user requirements coming from the wider business to define optimal functionality for the systems Form a strong partnership with Digital & Technology team, Quality Business Unit leads (Vaccines, B&D, PSM, MSDQ and EQ) to enable seamless and effective introduction and deployment of systems Core member of the QS&D leadership team, delegate for VP QS&D as required Basic Qualifications: BA/BS degree or equivalent in experience (Scientific, computing, or digital or engineering degree 10-15 years' experience in an IT or Quality function in a highly regulated environment Direct and relevant experience with Systems (including design, build, validate, deploy, maintain and sustain activities) Ability to work transversally in matrix organization, with global perspectives Ability to make independent decisions even under pressure and navigate in grey zones Strong interpersonal skills with demonstrated ability to engage, empower and influence people Ability to communicate complex information both orally and in writing Ability to adapt, work under uncertainty and accommodate flexible work demands Strong leadership skills to motivate, engage and develop team capabilities Ability to drive change and continuous improvement In depth understanding of cGMP and regulations applicable to GSK in the relevant countries. (FDA/EU/WHO and other countries) Ability to evaluate technical compliance and quality issues and make sound recommendations regarding problem resolution Preferred Qualifications: If you have the following characteristics, it would be a plus: Master's or PhD (Scientific, computing or engineering specialization) Previous experience as Business Owner for Enterprise Systems Demonstrated experience in delivering Systems across a diverse user base Experience with data and digital solutions in a regulated environment *LI-GSK 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.As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, 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*(*US only).We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on XXXX@gsk.com or 0808 234 4391. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive .As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially. 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-9c5e46a7-4710-45fa-9e58-6cbfa3f93361
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More About this Listing: Quality Assurance Systems Senior Director
Quality Assurance Systems Senior Director is a Quality Assurance QA Job at GSK located in Collegeville PA. Find other listings like Quality Assurance Systems Senior Director by searching Oodle for Quality Assurance QA Jobs.
Quality Assurance Systems Senior Director is a Quality Assurance QA Job at GSK located in Collegeville PA. Find other listings like Quality Assurance Systems Senior Director by searching Oodle for Quality Assurance QA Jobs.