Freya Wolles Email & Phone Number

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 (according to the ALCOA+CCEA standards) managing projects related to data integrity, providing computer system validation and 21 CFR part 11… Show more 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 (according to the ALCOA+CCEA standards) managing projects related to data integrity, providing computer system validation and 21 CFR part 11 expert knowledge where needed, contract partner assessments, follow up with, and supporting of contract partners in their DI remediation activities, processing and trending of data into KPIs and comprehensive reports that support strategic decisions and continuous improvement activities. Show less

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 partners and other stakeholders,…. Other Activities included: acting as Project Manager and business analysis for the improvement of the… Show more 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 partners and other stakeholders,…. Other Activities included: acting as Project Manager and business analysis for the improvement of the transportation management software. I worked closely with the business to analyze the as-is situation (development of narrative and process maps), identified pain points and improvement opportunities, and managed the project for the implementation of the improvements. Show less

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 combined with a deep technical knowledge on data integrity and software. She chose to come to the bay area because new technologies in pharma is one of her big passions in her work and she strives to help pharma companies in adapting these new technologies into their regulated… Show more 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 combined with a deep technical knowledge on data integrity and software. She chose to come to the bay area because new technologies in pharma is one of her big passions in her work and she strives to help pharma companies in adapting these new technologies into their regulated environments while still complying to the data integrity and 21 CFR part 11 regulations.She founded Quimera Quality Inc (partner of the QbD group of companies) and thanks to a strong business plan she was awarded with a E2 investor visa by the American Embassy enabling her to relocate to and work in the United States.Tasks included:• 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

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, budget planning and forecasting and on the people side she oversaw recruitment, motivated consultants and setup career development by… Show more 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, budget planning and forecasting and on the people side she oversaw recruitment, motivated consultants and setup career development by delegating these tasks to a dedicated Resource Manager. Responsible for the setup of the secure by design initiative which helped Ordina Belgium getting GDPR ready and helped in attaining an ISO27001 certification. Additionaly she studied the business trends and developments in order to create tailor made solutions for clients and prepared proposals. She has an extensive background in computer system validation (21 CFR Part 11, Annex 11, data integrity and ISO 9001 Quality Management Systems) and a keen interest in technology that she loved to combine with her day to day work as Unit Manager. Show less

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 projects

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: Internal CTG Project- CTG Academy Setup and implementation of a training methodologyOrganization and… Show more 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: Internal CTG Project- CTG Academy Setup and implementation of a training methodologyOrganization and leading of a one day course for new employees on the right part of the V-model (based on GAMP5)2006 – 2011: Assignment in the department Drug Safety Sciences at Johnson & Johnson (pre-clinical development).Coordination, implementation, validation and follow up for the setup of a telemetry system that is used in cardiovascular and respiratory GLP safety studies.Coordination, implementation, validation and follow up for a system to conduct Self Administration Studies Validation lead for the setup and validation of a Drug Addiction System to conduct drug discrimination learning studies. Responsible for several cardiovascular and toxicological systems. Show less

Master, Biochemistry, Graduated With Great Honors

Bachelor'S Degree, Biology, General, Graduated With Honors

Iso 9001: 2008 Lead Auditor Training Course

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

Prince2 ™ 2009 Foundation

Certified in Prince2 ™ Foundation (2009) Project Management

Education record