Sr Director, Quality Digital

1 month ago

Collegeville, Pennsylvania, United States GlaxoSmithKline Full time
Site Name: Upper Providence, Durham Blackwell Street, Philadelphia Walnut Street, Upper Merion
Posted Date: Jul

This Senior Tech leader will lead the global quality control systems Product Management team and will be accountable for driving the vision, strategy and executing the roadmap for all QC tech systems in Global Supply Chain and some related R&D business units. The role also partners with Business Owners to ensure the product lifecycle is effectively managed and prioritized.

Key Responsibilities:
  • Partner with the business stakeholders within Global Supply Chain (GSC) and R&D to create a sustainable Lab Automation and orchestration strategy for the lab of the future by identifying high value digital capabilities along with opportunities for Artificial Intelligence (AI) and Generative AI applications.
  • Ensure that quality control (QC) global business processes are designed and developed within the digital systems such as LIMS, Lab Execution Systems and scheduling, CDS and Environmental Monitoring.
  • Ensure alignment with other Smart Manufacturing initiatives within Global Supply Chain (GSC) to maximize business value and optimize cost by leveraging digital assets across GSC and the enterprise
  • Work collaboratively with global process owners (GPOs) and system owners within the Global Quality organization to keep QC digital strategy updated and aligned with the GSC Smart Manufacturing goals.
  • Manage MES requirements and capabilities roadmap to provide visibility to the business of upcoming product enhancements and features.
  • Lead on-time, under-budget value realization of global and enterprise-wide large technology delivery programs such as LES, across the Global Supply Chain (GSC) sites in both clinical and commercial manufacturing environments.
  • Member of the Global Quality Digital and Tech Leadership team and act as a delegate if required at the Global Quality Leadership Team(LT) and the GSC Digital & Tech LT.
  • Establish clear execution plans and ensure delivery of benefits to sites and end users in alignment with the Deployment Plan and successfully transition to steady state operations
  • Lead and motivate a high performing global team with deep subject matter expertise in Quality Control and pharmaceutical manufacturing systems domain, Agile development methodologies and digital product management
  • Manage and support business and digital risk identification and mitigation and adhere to necessary KPIs
  • Ensure that team members have clear annual objectives and robust personal development plans to enable growth and learning.
  • Ensure that team members have training plans to satisfy required quality and regulatory requirements pertaining to cGMP e.g., GMP, GLP and Good Documentation Practices (GDP).
  • Proactively manage and grow talent and ensure succession plans in place for key roles
  • Coach and develop direct reports and broader team to become effective team members that deliver valuable work, focused on data-driven decision making and customer centricity.
  • Leverage the knowledge of your internal team and external partners to develop reusable, standard, robust solutions to automate quality and manufacturing processes.
  • Maintain high credibility and strive to be ambitious for patients by delivering 10x business value through digital innovation
  • Develop of a product support model that ensures we can provide the sites with a reliable, maintainable system and access to expert resources when needed.


Why You?

Basic Qualifications:
  • BA/BS degree
  • 15 + years of professional experience
  • Direct experience in pharmaceutical laboratory testing activities, experience in managing laboratory and/or quality operations,
  • Pharma QC lab systems implementation and management of IT team and solutions
  • Experience and understanding of procedures to support GAMP5 guidance
  • Experience working in and supporting systems in a regulated GMP GxP environments


Preferred Qualifications:
  • Ability to travel 25-35% both domestic and internationally
  • Master of Science (MS) or PhD or an MBA strongly preferred.
  • Led teams that have developed successful software products from concept to adoption
  • Directly managed product managers/analysts and are passionate about developing people
  • You have experience of working within a matrixed organization with multiple stakeholders to manage
  • Have a broad and detailed understanding of product management techniques including customer development, discovery & primary research, lean start-up method and industrialization/scaling-up
  • Relevant certifications in GMP, GLP, Quality or Manufacturing technology or business processes.
  • Defined your own North-star Metric, KPIs sets and run your product teams using OKRs
  • Very deep understanding of Data Integrity principles related to ALCOA+ and their application to digital solutions
  • Proven experience in onboarding yourself and getting up to speed quickly on new products
  • Enough technical knowledge to understand your team's software products
  • You have lead teams that supported the life-cycle management of products and solutions in a manufacturing environment.
  • You have directly managed product developers/analysts and are passionate about developing people
  • You have experience of working within a matrixed organization with multiple stakeholders to manage
  • You know how to create and balance a healthy-tension between Product, UX & Design and Engineering
  • Experience in project lifecycle supporting medicines and vaccines manufacturing
  • Experience delivering projects in an Agile framework
  • Experience in working with international teams in multiple time zones
  • Familiarity with software quality assurance processes, testing methodologies, and release management and Computer Systems Validation (CSV) methodologies


#LI-GSK

#GSKTech1

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).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that 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.

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