Freya Wolles
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Freya Wolles Email & Phone Number

Senior Quality Leader - Passionate about new tech in pharma, expert in data integrity, Computer System Validation, 21 CFR Part 11 and Quality at GRAIL
Location: San Mateo, California, United States 7 work roles 5 schools
1 work email found @ordina.be 2 phones found area 650 LinkedIn matched
✓ Verified May 2026 4 data sources Profile completeness 100%

Contact Signals · 1 work email · 2 phones

Work email f****@ordina.be
Direct phone (650) ***-****
LinkedIn Profile matched
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Current company
GRAIL
Role
Senior Quality Leader - Passionate about new tech in pharma, expert in data integrity, Computer System Validation, 21 CFR Part 11 and Quality
Location
San Mateo, California, United States
Company size
479 employees

Who is Freya Wolles? Overview

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Quick answer

Freya Wolles is listed as Senior Quality Leader - Passionate about new tech in pharma, expert in data integrity, Computer System Validation, 21 CFR Part 11 and Quality at GRAIL, a company with 479 employees, based in San Mateo, California, United States. AeroLeads shows a work email signal at ordina.be, phone signal with area code 650, and a matched LinkedIn profile for Freya Wolles.

Freya Wolles previously worked as Director Data Integrity at Grail and Data Integrity and 21 CFR part 11 Specialist (Contractor) at Gilead Sciences. Freya Wolles holds Master, Biochemistry, Graduated With Great Honors from University Of Antwerp.

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Email format at GRAIL

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{first}.{last}@ordina.be
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Profile bio

About Freya Wolles

I am a quality professional with 17+ years of experience, specialized in computer system validation, (data integrity, 21 CFR Part 11, Annex 11, …), Data Integrity, Quality Management Systems and Project/Program Management with a keen interest in programming languages, data- and cyber security. This passion helps when evaluating systems and validation approaches in pharmaceutical environments. My quality expertise is combined with a strong leadership background. As Business Unit Manager Pharmaceutical Quality & Compliance Services at Ordina Belgium (2012-2018) I successfully developed the team and put Ordina Belgium on the map as provider for Quality services in the pharmaceutical industry. My main tasks included strategic- and business management combined with people management and business development (client contacts and setting up proposals). I have managed several complex CSV/quality IT/GxP projects in pharmaceutical environments and know how to combine the technical and quality aspects into the project approach (Experienced with project documentation, planning and follow up using MS Project and gannt chart). In 2016 I was keynote speaker at the ISPE Belgium event on IT Infrastructure Qualification & Control in Life Science Industry.I have professional experience at big companies like Johnson & Johnson and advising smaller companies on their validation approach. At Gilead Sciences in Foster City (start July 2018) I have extensive experience as Data Integrity Specialist (current position) and before that as program manager for the contract partner cybersecurity assessment initiative and project manager/business analyst. Next to that I also have experience in improving validation processes through gap/21 CFR part 11/data integrity assessments and have extensive background in computer system validation/qualification of custom made, configured, OTS software, Excel sheet, Instrument and associated software.

Listed skills include Gxp, Computer System Validation, Gamp, 21 Cfr Part 11, and 28 others.

Current workplace

Freya Wolles's current company

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GRAIL
Grail
Senior Quality Leader - Passionate about new tech in pharma, expert in data integrity, Computer System Validation, 21 CFR Part 11 and Quality
menlo park, california, united states
Website
grail.com
Employees
479
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7 roles

Freya Wolles work experience

A career timeline built from the work history available for this profile.

Director Data Integrity

Current
Grail
Apr 2024 - Present

Data Integrity And 21 Cfr Part 11 Specialist (Contractor)

Gilead Sciences

In March 2020 I moved to the Data Integrity team within LIS at Gilead Sciences, a team composed of Quality and DI industry experts that drives the global Data Integrity program for Gilead. My responsibilities include (but are not limited to) providing expert knowledge on the application of data integrity principles within the local and global DI program.

Feb 2020 - Apr 2024

Program Manager Contract Partner Cybersecurity Assessment Initiative (Contractor)

Gilead Sciences

In July 2018 I started in the LIS team at Gilead Sciences in Foster City and acted as program manager for the Contract Partner Cybersecurity Assessment Program. My responsibilities included (but were not limited to) process design and continuous improvement, assessment planning, on-site assessment execution and follow up, coordination with GSL, contract.

Jul 2018 - Feb 2020

Founder & Software Quality Expert

Quimera Quality

Redwood City, California

  • In march 2018 Freya started a new page in her career by moving from Europe to the United States of America. Her strengths in this are that she has a strong background in both FDA and European pharma regulations.
  • Definition of the company strategy and approach
  • Setup of the immigration file for the US embassy
  • Organization and follow up of the incorporation activities
  • Drafting incorporation documentation
  • Setup of the payroll system Show less
Feb 2018 - Jun 2022

Business Unit Manager Quality And Compliance

Ordina Belgium

As Business Unit Manager of the Q team she reported to the CEO of the company. It was Freya s main task to manage (including P&L responsibility) and follow up a team of 75 quality consultants. She had grown this team from 20 to 75 in less than 5 years and more than tripled the net profit of her department.She was responsible for the strategic, resource.

Sep 2012 - Jan 2018

Account Manager Testing & Quality Services

Sogeti

Responsible for sales cross sector for testing and Q&C services in Belgium with a special focus on the pharmaceutical sector.Main tasks included, but were not limited to:* Maintain existing client portfolio for both Testing and Q&C/pharma clients* Prospection and networking* Proposal writing including project and financial estimations* Follow up on ongoing.

May 2011 - Aug 2012

Senior Validation Engineer

Ctg

2009-2011: CTG Service Owner Vendor AuditsProject lead for the setup of an internal methodology/service regarding vendor audits inlcuding project planning, process, SOP and template development and providing training.2009-2011: CTG Service Member Project ManagementWorkgroup around creating a CTG project management methodology based upon Prince2. 2008-2009.

Oct 2006 - May 2011
Team & coworkers

Colleagues at GRAIL

Other employees you can reach at grail.com. View company contacts for 479 employees →

CC Christy Castle Christy Castle Colleague at GrailSuwanee, Georgia, United States, United States View → JF Jeanmarie Filisky Jeanmarie Filisky Colleague at GrailWashington, District Of Columbia, United States, United States View → KC Kelly Carlson Kelly Carlson Colleague at GrailSanta Cruz, California, United States, United States View → JV Julia Vandermeer Julia Vandermeer Colleague at GrailUnited States, United States View → RI Ryan Isaacs Ryan Isaacs Colleague at GrailWashougal, Washington, United States, United States View → KG Kelley Gabriel Kelley Gabriel Colleague at GrailAtlanta Metropolitan Area, United States View → SS Smit Shah Smit Shah Colleague at GrailSanta Clara, California, United States, United States View → JS Jamal Sirriyah Jamal Sirriyah Colleague at GrailRaleigh-Durham-Chapel Hill Area, United States View → HL Hyejung Lee Hyejung Lee Colleague at GrailGilroy, California, United States, United States View → MM Michael Miller, Mb(Ascp) Michael Miller, Mb(Ascp) Colleague at GrailRaleigh-Durham-Chapel Hill Area, United States View →
5 education records

Freya Wolles education

Iso 9001: 2008 Lead Auditor Training Course

Batalas

5 day training course on Quality Management System Auditing including written exam, which was completed succesfully.

Prince2 ™ 2009 Foundation

Exin

Certified in Prince2 ™ Foundation (2009) Project Management

Education record

Stedelijk Lyceum
FAQ

Frequently asked questions about Freya Wolles

Quick answers generated from the profile data available on this page.

What company does Freya Wolles work for?

Freya Wolles works for GRAIL.

What is Freya Wolles's role at GRAIL?

Freya Wolles is listed as Senior Quality Leader - Passionate about new tech in pharma, expert in data integrity, Computer System Validation, 21 CFR Part 11 and Quality at GRAIL.

What is Freya Wolles's email address?

AeroLeads has found 1 work email signal at @ordina.be for Freya Wolles at GRAIL.

What is Freya Wolles's phone number?

AeroLeads has found 2 phone signal(s) with area code 650 for Freya Wolles at GRAIL.

Where is Freya Wolles based?

Freya Wolles is based in San Mateo, California, United States while working with GRAIL.

What companies has Freya Wolles worked for?

Freya Wolles has worked for Grail, Gilead Sciences, Quimera Quality, Ordina Belgium, and Sogeti.

Who are Freya Wolles's colleagues at GRAIL?

Freya Wolles's colleagues at GRAIL include Christy Castle, Jeanmarie Filisky, Kelly Carlson, Julia Vandermeer, and Ryan Isaacs.

How can I contact Freya Wolles?

You can use AeroLeads to view verified contact signals for Freya Wolles at GRAIL, including work email, phone, and LinkedIn data when available.

What schools did Freya Wolles attend?

Freya Wolles holds Master, Biochemistry, Graduated With Great Honors from University Of Antwerp.

What skills is Freya Wolles known for?

Freya Wolles is listed with skills including Gxp, Computer System Validation, Gamp, 21 Cfr Part 11, Sop, Validation, Testing, and Quality Control.

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