Site Quality Head Clinical Packaging Schwitzerland
CurrentDepartment Head. Final release of labelled/packaged investigational medicinal products for clinical trials worldwide.FvP/RP Deputy
Dec 2018 - Present
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Stephanie Sutter Email & Phone Number
Site Quality Head Clinical Packaging Schwitzerland
at
Roche
1 work email found
@novartis.com
LinkedIn matched
✓ Verified August 2026
4 data sources
Profile completeness 100%
Current company
Role
Site Quality Head Clinical Packaging Schwitzerland
Location
Kembs, Grand Est, France
Company size
Who is Stephanie Sutter? Overview
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Quick answer
Stephanie Sutter is listed as Site Quality Head Clinical Packaging Schwitzerland at Roche, a with 90641 employees, based in Kembs, Grand Est, France. AeroLeads shows a work email signal at novartis.com and a matched LinkedIn profile for Stephanie Sutter.
Stephanie Sutter previously worked as Head Release Team at Roche and Quality Manger at Roche. Stephanie Sutter holds Master En Biologie, Option Assurance Qualité from Universite De Strasbourg.
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Email format at Roche
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{first}.{last}@novartis.com
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Profile bio
About Stephanie Sutter
Stephanie Sutter is a Site Quality Head Clinical Packaging Schwitzerland at Roche. She possess expertise in gmp, validation, glp, technology transfer, biopharmaceuticals and 7 more skills. She is proficient in English and German.
Listed skills include Gmp, Validation, Glp, Technology Transfer, and 8 others.
Current workplace
Stephanie Sutter's current company
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Roche
7 roles
Stephanie Sutter work experience
A career timeline built from the work history available for this profile.
Head Release Team
Final release of labelled/packaged investigational medicinal products for clinical trials worldwide. FvP/RP Deputy
Quality Manger
Release of Investigiational Medicinal Products for human use and world wide distribution, QA Manager, Issue Manager, GMP Auditor, GMP Expert, Complaint Manager, Trackwise for Change Control & Discrepancies & CAPA, Regulatory Compliance, GMP Compliance, Project Management, SAP
Mar 2013 - Apr 2017
External Qa Expert
The same responsibilities as Head just change to Expert after Process Organisation Orientation implementation (POO organization)
Jan 2011 - Feb 2013
Head External Quality
Responsible for the GMP approval of third parties for outsourced testing and raw material and consumables suppliers. Responsible for related change control management and deviations. Handling of change reaquests and deviations via Trackwise system.Responsible for raw material management. In charge of raw material approvaland release before use in production. Deviation management linked to raw materials.Experience with the elaboration of quality agreements with third parties and suppliers. Coordination of the site audit program (internal and external audits). Responsible for Inspections related CAPA plans.Coordination of Health Autorities inspections (FDA, ANVISA, AFSSAPS ect.). Inspection preparation, execution, writing of daily reports, and CAPA plan follow up.Responsible for the implementation and follow up of the actions linked to the Site Quality Risk Assessment and Quality Plan.
Sep 2009 - Jan 2011
Qualification Coordinator
Responsible for all qualifcation for Utilities-support equipment and HVAC during the construction of the new facility for the Basiliximab production.Design and implementation of the equipments qualification strategy for the WFI, purified water, steam and gas systems. Strategy definition for the HVAC system qualification and outsourced testing. Responsible for the release of support equipment (washing machine, laminar et isolator) as required by the protocol and users´ requirements.
Jan 2008 - Sep 2009
Sampling Group And Microbiological Lab Head
Sampling plan management. Responsible for the microbiological testing transfer from PharmOps site to BiotechOps site. Responsible for the environmental data, bioburden testing done in the manufacturing area, trending, and handling of out of specifications. Responsible for the stability management.
Feb 2003 - Jan 2008
Team & coworkers
Colleagues at Roche
Other employees you can reach at roche.com. View company contacts for 90641 employees →
JL
Jennifer Lanning
Colleague at RocheGreater Fort Wayne, United States
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LO
Lisa Ong
Colleague at RocheSingapore
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RK
Rüdiger Kolm
Colleague at RocheGreater Munich Metropolitan Area, Germany
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AH
Ashlee Huff
Colleague at RocheIndianapolis, Indiana, United States
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陈
陈子妍
Colleague at RocheToronto, Ontario, Canada
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OR
Oscar Renato Ocón Prado
Colleague at RochePanama
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LP
Lotta Paulina Krüger
Colleague at RocheDortmund, North Rhine-Westphalia, Germany
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EK
Elena Koneva
Colleague at RocheMeilen, Zurich, Switzerland
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DV
Dhara Vora , M.Pharm
Colleague at RocheMississauga, Ontario, Canada
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JS
Jenny Sabogal Rodríguez
Colleague at RocheColombia
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Jennifer Lanning
Colleague at RocheGreater Fort Wayne, United States
View →
LO
Lisa Ong
Colleague at RocheSingapore
View →
RK
Rüdiger Kolm
Colleague at RocheGreater Munich Metropolitan Area, Germany
View →
AH
Ashlee Huff
Colleague at RocheIndianapolis, Indiana, United States
View →
陈
陈子妍
Colleague at RocheToronto, Ontario, Canada
View →
OR
Oscar Renato Ocón Prado
Colleague at RochePanama
View →
LP
Lotta Paulina Krüger
Colleague at RocheDortmund, North Rhine-Westphalia, Germany
View →
EK
Elena Koneva
Colleague at RocheMeilen, Zurich, Switzerland
View →
DV
Dhara Vora , M.Pharm
Colleague at RocheMississauga, Ontario, Canada
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JS
Jenny Sabogal Rodríguez
Colleague at RocheColombia
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2 education records
Stephanie Sutter education
Master En Biologie, Option Assurance Qualité
Universite De Strasbourg
Sport Étude, Tir À L'Arc
Insep À Paris
FAQ
Frequently asked questions about Stephanie Sutter
Quick answers generated from the profile data available on this page.
What company does Stephanie Sutter work for?
Stephanie Sutter works for Roche.
What is Stephanie Sutter's role at Roche?
Stephanie Sutter is listed as Site Quality Head Clinical Packaging Schwitzerland at Roche.
What is Stephanie Sutter's email address?
AeroLeads has found 1 work email signal at @novartis.com for Stephanie Sutter at Roche.
Where is Stephanie Sutter based?
Stephanie Sutter is based in Kembs, Grand Est, France while working with Roche.
What companies has Stephanie Sutter worked for?
Stephanie Sutter has worked for Roche and Novartis.
Who are Stephanie Sutter's colleagues at Roche?
Stephanie Sutter's colleagues at Roche include Jennifer Lanning, Lisa Ong, Rüdiger Kolm, Ashlee Huff, and 陈子妍.
How can I contact Stephanie Sutter?
You can use AeroLeads to view verified contact signals for Stephanie Sutter at Roche, including work email, phone, and LinkedIn data when available.
What schools did Stephanie Sutter attend?
Stephanie Sutter holds Master En Biologie, Option Assurance Qualité from Universite De Strasbourg.
What skills is Stephanie Sutter known for?
Stephanie Sutter is listed with skills including Gmp, Validation, Glp, Technology Transfer, Biopharmaceuticals, Pharmaceutical Industry, Chromatography, and Biotechnology.
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