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 1 month

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

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
Lorem ipsum dolor sit amet

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

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