Manager Clinical Quality Assurance
Current
Oct 2018 - Present
AeroLeads people directory · profile
Birgit Felber Email & Phone Number
Manager Clinical Quality Assurance
at
Octapharma
1 work email found
@octapharma.com
LinkedIn matched
✓ Verified August 2026
4 data sources
Profile completeness 86%
Who is Birgit Felber? Overview
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Quick answer
Birgit Felber is listed as Manager Clinical Quality Assurance at Octapharma, based in Vienna, Austria. AeroLeads shows a work email signal at octapharma.com and a matched LinkedIn profile for Birgit Felber.
Birgit Felber previously worked as Program QA & Compliance Lead (Clinical & Medical QA & Compliance) at Baxalta (Now Part Of Shire) and Compliance Project Manager, Clinical Quality Management at Baxalta (Before: Baxter). Birgit Felber holds Diplom-Ingenieurin (Di, Comparable To A Master Of Science), Food Science And Biotechnology from Universität Für Bodenkultur, Wien.
Company email context
Email format at Octapharma
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{first}.{last}@octapharma.com
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Profile bio
About Birgit Felber
• 15+ years of experience in clinical research (clinical quality management and clinical operations) in all phases and various indications• Sound knowledge of ICH-GCP and proven ability to investigate local requirements• Experience in GCP inspection preparation and support (EMA, PMDA, FDA, MHRA), GCP audits (investigator sites, trial master files, CROs) and investigator site monitoring (conduct and co-monitoring)• Proven ability to identify and independently solve issues or follow up on satisfactory resolution by others, as appropriate• Demonstrated attention to detail• Genuine passion about supporting and mentoring others in order to achieve high quality
Current workplace
Birgit Felber's current company
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7 roles
Birgit Felber work experience
A career timeline built from the work history available for this profile.
Program Qa & Compliance Lead (Clinical & Medical Qa & Compliance)
Baxalta (Now Part Of Shire)
Main responsibilities:• Created and executed Program Compliance and Audit Plans for assigned programs (Hemophilia)• Provided compliance support to study teams for assigned programs (Hemophilia, Biosimilars)• Supported preparation and conduct of GCP inspections (EMA, PMDA, FDA, MHRA)
Jan 2017 - Mar 2018
Compliance Project Manager, Clinical Quality Management
Baxalta (Before: Baxter)
Main responsibilities:• Supported oversight of QA activities in a newly established sponsor-CRO-partnership• Reviewed audit reports and corrective and preventive action plans and assured appropriate and timely distribution (across all programs)• Conducted and outsourced audits (investigator sites, trial master files, CROs; Vaccines, Hemophilia)• Developed Clinical Quality Management and Audit Plans• Provided compliance support to study teams• Supported preparation and conduct of GCP inspections (EMA, MHRA)• Supported exception reporting within Clinical R&D
May 2008 - Dec 2016
Lead Clinical Research Associate
Baxter
Lead CRA for a Biosurgery Study (Phase II) sponsored by Kuros Bioscience AGMain responsibilities:• Supported Clinical Project Managers• Reviewed monitoring visit reports• Performed co-monitoring visits (across Europe)• Developed and provided training to CRAs and investigators• Identified various documents needing improvement (e.g. drug accountability forms, Clinical Monitoring Plan) and successfully implemented those
Aug 2007 - Apr 2008
Medical Advisor (Neurology) / Study Management
Schering Austria
Main responsibilities:• Clinical Research Associate / Local Study Coordinator responsibilities as listed below• Managed Post Authorization Studies• Provided scientific support to the business unit• Answered physicians’ and patients’ questions
Jan 2006 - May 2007
Clinical Research Associate
Schering Austria
Main responsibilities:• Planned, conducted and reported onsite monitoring visits in Austria (Phase III, Multiple Sclerosis, Gynecology) • Local Study Coordinator for three clinical studies (Phase III, Multiple Sclerosis) for Austria• Performed Independent Ethics Committee and Regulatory Authority submissions• Adapted study documents to fulfill local requirements• Managed investigational product supply and destruction• Provided training and mentoring to newly hired Clinical Research Associates
Mar 2004 - Dec 2005
Clinical Research Associate
Skm Oncology Research
• Received initial training on the job• Conducted and reported first independent monitoring visits (Phases II/III, Oncology) in Germany• Provided CRF entry support to clinical study sites (Oncology) in Germany
Oct 2003 - Mar 2004
4 education records
Birgit Felber education
Diplom-Ingenieurin (Di, Comparable To A Master Of Science), Food Science And Biotechnology
Universität Für Bodenkultur, Wien
Education record
Czech Academy Of Sciences
Food Science And Technology
University College Cork
Education record
University Of Ljubljana, Faculty Of Biotechnology
FAQ
Frequently asked questions about Birgit Felber
Quick answers generated from the profile data available on this page.
What company does Birgit Felber work for?
Birgit Felber works for Octapharma.
What is Birgit Felber's role at Octapharma?
Birgit Felber is listed as Manager Clinical Quality Assurance at Octapharma.
What is Birgit Felber's email address?
AeroLeads has found 1 work email signal at @octapharma.com for Birgit Felber at Octapharma.
Where is Birgit Felber based?
Birgit Felber is based in Vienna, Austria while working with Octapharma.
What companies has Birgit Felber worked for?
Birgit Felber has worked for Octapharma, Baxalta (Now Part Of Shire), Baxalta (Before: Baxter), Baxter, and Schering Austria.
How can I contact Birgit Felber?
You can use AeroLeads to view verified contact signals for Birgit Felber at Octapharma, including work email, phone, and LinkedIn data when available.
What schools did Birgit Felber attend?
Birgit Felber holds Diplom-Ingenieurin (Di, Comparable To A Master Of Science), Food Science And Biotechnology from Universität Für Bodenkultur, Wien.
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