External Supply Investigator

Collegeville, PA
December 18 2020
Other, Other
Organization Type
Are you looking for an opportunity to manage the interface with external partners? The External Supply Investigator (ESI) is responsible for managing the relationship with the external partners, ensuring adherence to the contract terms while maintaining a positive relationship with the partner. The ESI is also responsible for implementing relationship-specific KPls and monitoring performance against them.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
  • Managing activities and/or services provided by external suppliers/contractors, including support of negotiation of timelines, costs, and deliverables for such work packages
  • Develops relationships with internal partners and external suppliers whilst maintaining the highest level of professional and ethical conduct
  • Significant external influencing required ensuring alignment of GSK business requirements with supplier's expectations. Ensures protection of GSK IP in all Supplier interactions
  • Influences organizational thinking and/or research and development activities by leveraging their scientific or technological expertise
  • Provide person in plant support for key activities at external partners
  • Leads joint teams with external parties tasked with manufacture and testing/release of CGT products
  • Effectively communicates across extended matrix teams comprising CGT, QA, Program/ Project Teams/ GSK Procurement organizations, and external supplier organizations
  • Contributes to global outsourcing policies and third party oversight for CGT / R&D
  • Participates in performance reviews of preferred suppliers. Coordinates, manages & reports Key Performance Indicators (Performance measures) on a regular basis
  • Proactively defines and implements CGT CMC and sourcing plans, critically evaluating these against business requirements to ensure project objectives are met.
  • Develops contingency plans and proposes alternative strategies as appropriate
  • May be required to provide direct oversight of development/ cGMP activities and may support due diligence activities with some travel required
  • Initiates and implements continuous improvements in ways of working
  • Responsible for monitoring the integrity and quality of partner derived data ensuring it is suitable to support robust manufacturing/ testing and associated GSK regulatory filings
  • Reviews and approves 3rd party investigations and change control
  • Provides technical advice and interfaces with development group when needed for troubleshooting

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Bachelors of Science or Engineering
  • 3-5 years in a GMP setting
  • Experience in Leading, Writing and Reviewing Investigations and Change Controls

Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Masters Degree in Science or Engineering
  • >2 years in a GMP manufacturing setting
  • Cell processing and or cell culture experience
  • Understanding of Bioassays such as cell count, viability, and flow assays
  • Project Management Experience
  • Contract negotiations with 3rd Parties
  • Prior 3rd party oversight experience

Why GSK?

Our values and expectationsare at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
  • Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Continuously looking for opportunities to learn, build skills and share learning.
  • Sustaining energy and well-being.
  • Building strong relationships and collaboration, honest and open conversations.
  • Budgeting and cost-consciousness.


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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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