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Process Manager, Deviation and CAPA

3 months ago

King of Prussia, Pennsylvania, United States GlaxoSmithKline Full time
Site Name: USA - Pennsylvania - King of Prussia, Belgium-Wavre, UK - Hertfordshire - Stevenage, UK - Hertfordshire - Ware, UK - London, USA - North Carolina - Durham, USA - Pennsylvania - Philadelphia
Posted Date: Aug

The purpose of the Process Manager, Deviation and CAPA is to work with the Global Business Process Owner (GBPO) in maintaining, sustaining and improving Deviation, Investigation and CAPA Process, Application, Data and/or Digital solutions. Activities may include leading global forums, providing expertise and support to business partners, driving improvement projects, defining and executing metrics/KPIs, acting as voice of the business for Tech projects, and driving change management with the business.

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

Reporting to the Quality Systems and Data Process Senior Director and working at the Direction of the GBPO, Deviation and CAPA, along with key business stakeholders:
  • Globally own and manage process, application, data and digital for deviation, CAPA and related processes for the Enterprise.
  • Responsible for/ Engaged in activities supporting "Business as Usual" for deviation and CAPA from a process, application, data and/or digital perspective. Providing guidance, support, problem resolution, etc. across the user community.
  • Instrumental in driving the simplification, standardization and seamless deployment of deviation and CAPA processes. Provide input to the process policies and GQSOPs, application, data and digital solutions associated with the process. Support implementation through gap/implementation assessment and tackling barriers to successful implementation at sites/LOCs.
  • Facilitate communities of practice (CoP) or Councils across the network, to include R&D, Supply Chain, Commercial and Global Functions. Liaise with SMEs throughout the process: impact assessment, design, review, implementation. Responsible for ensuring the SME list is accurate.
  • Support audit preparation and resolution of findings across the network, acting as an audit coach as needed.
  • Where appropriate, facilitate the development and deployment of global tools and training content related to deviation and CAPA processes.
  • In partnership with business stakeholders and Tech, consolidate and define User Requirements for existing or new Tech solutions. Facilitate or participate in testing and deployment activities to ensure organizational adoption.
  • Provide input into development of key performance indicators, global data review and trending of KPIs providing a mechanism for oversight of the process from a local to global perspective, ultimately facilitating quality management maturity.
  • Responsible for owning, monitoring and progressing global Quality records related to the deviation and CAPA processes (SAP, Veeva QMS, etc.), as required
  • Act as Local Lead and Super User for Quality Systems & Data Organization. Assist with access provisioning, training, troubleshooting, monitoring and execution for QS&D Team Members.
  • Maintain knowledge of global regulations and guidance, global regulatory and pharmacopeial expectations, inspection intelligence, innovative/new technologies, industry standards and registered risks pertaining to area of expertise and act as Subject Matter Expert in providing input/guidance to the network. Represent GSK in external advocacy and sharing best practices.


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Bachelor's degree
  • 2+ years' experience with deviation, investigation, and CAPA process or tools
  • 2+ years' experience with quality management software systems (i.e. Veeva, Trackwise, SAP)
  • Knowledge of and experience with global regulations related to deviation, investigation and/or CAPA (FDA, MHRA, EMA, etc.)
  • 2+ years' experience in a GxP regulated environment (GCP, GMP, GDP, etc.)
  • 5+ years' experience in pharma, biopharma, vaccines, or medical device
  • Project management experience


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Master's degree
  • Experience leading or participating in digital/data projects (reporting tools, AI, intelligent automation)
  • Solid team player able to function within team-based organization
  • Strong verbal and written communication skills
  • Able to interact with peers, subordinate and senior personnel in multidisciplinary environment


#LI-GSK

Please visit GSK US Benefits Summary t o 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.

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