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A Range of Possibilities

Senior Principal Investigator

date posted 08/14/2019
contract type Full time
job id R2519156
location East Swiftwater, Pennsylvania; Swiftwater, Pennsylvania

Senior Principal Investigator, FFIP - Swiftwater, PA

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Lead complex investigations, gain consensus from all levels of support groups and resolve issues that impact the supply of FFIP products.  Support deviation investigations deemed important to the safety, quality, efficiency and effectiveness of the FFIP factory.  Serve as the FFIP Senior Principal Investigator and interface with multiple cross functional teams for deviation resolution.      

  • Writing and resolution of Major/Critical deviations in order to meet production and product release.
  • Leads complex investigations such as Sterility Failures, Growth Promotion, OOS, Customer Complaints and Trend investigations using advanced RCA tools (6Ms, Cause-Effect, Is-Is Not, 5Whys, kaizens, etc).
  • Facilitates cross-functional interfacing activities with stakeholders in a very positive manner to obtain consensus in order to facilitate deviation closure: Quality Control, Manufacturing Technology, Sterility Assurance and Quality Assurance.
  • Work cross functionally with many area functions, to develop and write CAPA related to deviations.
  • Leads the resolution to unresolved issues and deliverables by leading meetings, positively influencing functional manager, removing obstacles and managing projects and priorities, which are critical to ensuring critical lot release.
  • Manage multiple priorities either independently or part of a team in order to meet key deadlines and communicate issues and progress across all levels of organization.
  • Accurately communicate (both written and verbal) progress and updates across multiple levels of the organization and regulatory agencies
  • Required to possess and demonstrate excellent interpersonal/communication skills through influence skills, flexibility and the ability to lead and participate on teams. 
  • Review deviations for completeness and performs Manager or Director review as needed.
  • Must be able to work extended and flexible hours (including weekends) when needed.  

Key Accountability:

  • Very high level of technical writing, investigation and resolution of complex Major or Critical deviations by leading investigations with multiple cross functional support groups using advanced RCA tools. 
  • Review deviations for completeness written by Principal Investigators and perform Manager or Director review of minor and major events prior to the review by Quality Assurance. 
  • Leads cross functional meetings with multiple departments for the development and executes the writing of CAPAs related to deviation corrective and preventive actions.
  • Leads cross functional interfacing activities independently with key stakeholders in a very positive manner to obtain consensus on items needed for deviation closure. 
  •  Manage multiple high profile priorities independently to meet key deadlines and accurately communicate escalation of roadblocks to upper management.
  • Ensure compliance with all regulatory requirements and good documentation practices are followed to provide a safe, quality, and effective product and interface with Regulatory Agencies to defend deviation investigations.

Basic Qualifications:

  • Bachelor Level degree in Life Sciences and 5 – 7 years experience in a GMP environment 
  • Previous experience working within a production department of a pharmaceutical company preferred
  • Must have technical writing skills
  • Working knowledge of cGMPs
  • Must have knowledge of continuous improvement techniques and RCA problem solving skills
  • Must be able to work extended and flexible hours (including weekends) when needed.  

Grade:  L2-1

If you want to learn more about compensation grades, please go to our grade guide via the following link:

http://mysanofi.sanofi.com/sites/HR-Corporate/Pages/eEdiPrVI/Global_Grading.aspx

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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