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Alexander Hinkis

Co-Founder and CEO

Alexander Hinkis
Vienna, Austria

Experience

May 2024 - Dec 2024
8 months

QMS Senior Specialist

Abbott GmbH

  • Conducted technical QMS assessments of the corporate complaints platform
  • Estimated effort for the upgrade activity
  • Developed a high-level data migration plan
  • Coordinated with the software vendor on required adjustments
  • Developed a proof of concept and presented it to business stakeholders
Mar 2024 - Oct 2024
8 months

QA Specialist

Alvotech

  • Led quality efforts to prepare the organization for GxP audits
  • Drafted, revised, and reviewed IT SOPs
  • Conducted internal audits and managed findings
  • Coordinated with IT and QA teams on CAPA resolutions
  • Worked with IT providers on software and hardware upgrades
  • Qualified lab equipment hardware and software
Jan 2024 - Present
2 years 2 months

Support Specialist

Abbott Products Operations AG

  • Provided 2nd-level support for lab software: NeoLiCy (method validation) and DryLab (method development)
  • Communicated with business stakeholders and the IT system owner
  • Monitored and resolved support tickets
Jan 2023 - Jul 2023
7 months

Support Specialist

Dräger

  • Supported the quality system (Trackwise)
  • Communicated with IT and QA stakeholders
  • Advised on processes and shared best practices
Sep 2022 - Oct 2023
1 year 2 months

IT Project Manager

Abbott Products Operations AG

  • Implemented lab management systems: NeoLiCy (method validation) and DryLab (method development)
  • Gathered requirements
  • Authored project plans
  • Planned and reported on budgets
  • Led validation deliverables
Jan 2022 - Dec 2023
2 years

Cyber Security Expert

Abbott Products Operations AG

  • Authoring divisional SOP for cyber security
  • Authoring cyber security training material for Abbott EPD sites
  • Leading cyber security audit preparation with sites’ representatives
  • Review of existing cyber documentation and gap analysis
  • CAPAs drafting and mitigation planning
Dec 2021 - Apr 2023
1 year 5 months

System Architect

BioNTech SE

  • Lead architecture activities within QA digital solutions team
  • QMS systems landscape design
  • RFP system selection use cases drafting, migration and interface analysis and design
  • Batch release systems selection and requirements gathering
  • Data migration lead
Sep 2021 - Oct 2022
1 year 2 months

Project Manager

Merck KGaA

  • Support the business partner unit with all-around project activities
  • Financial reporting and budget allocation
  • IT stakeholders management
  • Collaboration with business project leads in project activities
  • Project planning
  • Reporting and collaboration with senior management
Jul 2021 - Dec 2021
6 months

Interim Business Relationship Manager Supply Chain

Abbott Healthcare Products BV

  • Lead of global rollout for manufacturing and process data collection with OSIsoft Pi
  • Budget and staffing responsibility for supply chain program within division’ ERP and MDM systems
  • Budget forecasting and analysis
  • Requirements analysis, RFP reviews and member of steering committee
Jan 2021 - Jun 2021
6 months

QMS Trackwise Consultant

Boehringer Ingelheim

  • Supplier risk management and supplier qualification process design
  • Trackwise configuration
  • Crystal reports development
  • GxP documentation authoring
Mar 2020 - Dec 2020
10 months

Requirements Engineer

Sartorius Stedim Systems GmbH

  • CAF (Cross application functions) requirements definition and specification
  • Work items (features, use-case, change requests, tasks and ideas) process definition in Polarion ALM
  • Features introduction and refinement
  • Member of requirements management team
  • Iterative product development within software development and testing teams
  • Pharmaceutical manufacturing processes expert (Deviation, Investigation, CAPA, Change Control etc.)
Feb 2019 - Jan 2020
1 year

QMS Delivery Consultant

Abbott Nutrition

  • Device complaints solution implementation
  • Requirements design according to GAMP5
  • Market analysis and regulatory standards introduction
  • Stakeholders workshops lead
  • User stories and URS authoring
  • UAT and validation activities lead
  • GxP platform launch and hypercare lead
Jan 2019 - Jul 2019
7 months

Data Migration Architect

Leo Pharma

  • Quality and compliance processes design
  • Source to target architecture definition
  • Data objects structuring
  • Hands on utilization of Trackwise QMS and Veeva Vault automation tools
  • Veeva certified administrator
Jun 2017 - Dec 2018
1 year 7 months

QMS Trackwise Consultant

Boehringer Ingelheim

  • Data migration lead (Merial animal health acquisition)
  • Meetings with stakeholders and business analysis
  • GxP documentation approver
  • Assistance with project management activities
Nov 2016 - Dec 2018
2 years 2 months

Project Manager and Process Owner

Merck KGaA

  • GxP agile project manager with budgets of 2M € and above
  • Scrum master and team manager in a matrix organization
  • Software product requirements specification and RFP management
  • Presentations and collaboration with senior management
  • Financial reporting and budget allocation

Industries Experience

See where this freelancer has spent most of their professional time. Longer bars indicate deeper hands-on experience, while shorter ones reflect targeted or project-based work.

Experienced in Pharmaceutical (7.5 years), Healthcare (5.5 years), Chemical (3 years), Biotechnology (2 years), and Food and Beverage (1 year).

Pharmaceutical
Healthcare
Chemical
Biotechnology
Food and Beverage

Business Areas Experience

The graph below provides a cumulative view of the freelancer's experience across multiple business areas, calculated from completed and active engagements. It highlights the areas where the freelancer has most frequently contributed to planning, execution, and delivery of business outcomes.

Experienced in Quality Assurance (6 years), Information Technology (6 years), Project Management (4 years), Finance (3.5 years), Product Development (3 years), and Operations (1 year).

Quality Assurance
Information Technology
Project Management
Finance
Product Development
Operations

Summary

I am an energetic leader with over 15 years of international experience in the life science industry, including pharmaceuticals, biopharma, and medical devices. I'm passionate about matching business needs with technology and data-driven ecosystems. Being open-minded, constructive, and open to feedback helps me bring people together around a clear vision. I love being part of a global organization that encourages excellence, drives continuous improvement, and values its most important asset- its people.

Languages

English
Native
Hebrew
Native
Russian
Native
German
Intermediate
Spanish
Elementary

Education

Oct 2014 - Jun 2016

GISMA Business School (Maastricht School of Management)

Master of Business Administration, International Business specialization · International Business · Hanover, Germany

Oct 2004 - Jun 2008

Technion, Israel Institute of Technology

Bachelor of Science in Industrial Engineering and Management, Information Technologies specialization · Industrial Engineering and Management · Haifa, Israel

Oct 1995 - Jun 1999

Full matriculation in science · Science (Mathematics, Physics, Computer science)

Certifications & licenses

Salesforce certified administrator

TOGAF 9.2

Trackwise Digital

Trackwise certified trainer

Veeva Vault Administrator White Belt

Profile

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Frequently asked questions

Do you have questions? Here you can find further information.

Where is Alexander based?

Alexander is based in Vienna, Austria.

What languages does Alexander speak?

Alexander speaks the following languages: English (Native), Hebrew (Native), Russian (Native), German (Intermediate), Spanish (Elementary).

How many years of experience does Alexander have?

Alexander has at least 9 years of experience. During this time, Alexander has worked in at least 13 different roles and for 11 different companies. The average length of individual experience is 1 year and 7 months. Note that Alexander may not have shared all experience and actually has more experience.

What roles would Alexander be best suited for?

Based on recent experience, Alexander would be well-suited for roles such as: QMS Senior Specialist, QA Specialist, Support Specialist.

What is Alexander's latest experience?

Alexander's most recent position is QMS Senior Specialist at Abbott GmbH.

What companies has Alexander worked for in recent years?

In recent years, Alexander has worked for Abbott GmbH, Alvotech, Abbott Products Operations AG, Dräger, and BioNTech SE.

Which industries is Alexander most experienced in?

Alexander is most experienced in industries like Pharmaceutical, Healthcare, and Chemical. Alexander also has some experience in Biotechnology and Food and Beverage.

Which business areas is Alexander most experienced in?

Alexander is most experienced in business areas like Information Technology (IT), Quality Assurance (QA), and Project Management. Alexander also has some experience in Finance, Product Development, and Operations.

Which industries has Alexander worked in recently?

Alexander has recently worked in industries like Healthcare, Pharmaceutical, and Biotechnology.

Which business areas has Alexander worked in recently?

Alexander has recently worked in business areas like Information Technology (IT), Quality Assurance (QA), and Project Management.

What is Alexander's education?

Alexander holds a Master in International Business from GISMA Business School (Maastricht School of Management) and a Bachelor in Industrial Engineering and Management from Technion, Israel Institute of Technology.

Does Alexander have any certificates?

Alexander has 5 certificates. Among them, these include: Salesforce certified administrator, TOGAF 9.2, and Trackwise Digital.

What is the availability of Alexander?

Alexander is immediately available for suitable projects.

What is the rate of Alexander?

Alexander's rate depends on the specific project requirements. Please use the Meet button on the profile to schedule a meeting and discuss the details.

How to hire Alexander?

To hire Alexander, click the Meet button on the profile to request a meeting and discuss your project needs.

Average rates for similar positions

Rates are based on recent contracts and do not include FRATCH margin.

1000
750
500
250
Market avg: 800-960 €
The rates shown represent the typical market range for freelancers in this position based on recent contracts on our platform.
Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.