Alexander Hinkis
Co-Founder and CEO
Experience
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
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
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
Support Specialist
Dräger
- Supported the quality system (Trackwise)
- Communicated with IT and QA stakeholders
- Advised on processes and shared best practices
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
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
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
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
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
QMS Trackwise Consultant
Boehringer Ingelheim
- Supplier risk management and supplier qualification process design
- Trackwise configuration
- Crystal reports development
- GxP documentation authoring
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.)
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
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
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
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).
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).
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
Education
GISMA Business School (Maastricht School of Management)
Master of Business Administration, International Business specialization · International Business · Hanover, Germany
Technion, Israel Institute of Technology
Bachelor of Science in Industrial Engineering and Management, Information Technologies specialization · Industrial Engineering and Management · Haifa, Israel
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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