Harsh Thakkar

Qualtivate

Clients who have trusted our expertise:

- Rho Inc
- ICON PLC
- Immuneering
- G1 Therapeutics 
- Seres Therapeutics 
- and many more since 2022

Our why:

Help life sciences elevate their quality management and build innovative technologies to make data-driven decisions throughout the product development lifecycle.

4 ways we deliver value:

1. Quality Management & Compliance 
2. Computer Systems Lifecycle Management 
3. Data Governance & Integrity 
4. Custom App Development 

How we can help you:

- Auditing your software and quality systems.
- Prepping sites for GMP.
- Full management of your computer systems.
- Qualifying infrastructure and equipment.
- Training for FDA and regulatory audits.
- Oversight of all GxP QA activities.
- Building smart AI and no-code apps.
- Shifting from paper to digital QMS.
- Moving from validation to software assurance.
- Managing your external suppliers network.
- Crafting a solid data governance strategy.
- Building data-driven supply chains.

How to get in touch?

1) Word of mouth via our happy clients and business partners.

2) Or good old email and phone:

📞 Call us: +1-919-213-8737
📧 Email: hthakkar@qualtivate.com
🌐 Visit: www.qualtivate.com

CEO and Founder

Life Sciences 360

Life Sciences 360 is a podcast and YouTube channel that educates anyone on challenges, trends, and insights in the life-sciences industry. 

As the host, I interview subject-matter experts, CXOs, business leaders, and key life-science partners contributing to bringing new therapies to patients worldwide. 

I'm passionate about advancements in life sciences and technology and always eager to learn from guests— making the show both informative and useful for the audience.

Podcast Host and Producer

Cytokinetics

Associate Director Quality Assurance GxP Electronic Systems

Bristol Myers Squibb

Sr. Manager Quality Assurance- GxP Systems

Manager Quality Assurance GxP Systems

White Collar Technologies, Inc

Consulted for 
- Millennium Pharmaceuticals (acquired by Takeda)
- Biogen
- Myonex (formerly Myoderm)
- Merck
- Johnson & Johnson (led projects for JnJ Consumer, Janssen and Ethicon)

Senior Quality and CSV Consultant

Dr. Reddy's Laboratories

Regulatory Affairs Specialist

Pfizer

QC Analyst

CEO @ Qualtivate- consultancy helping life sciences to elevate quality management maturity, ensure regulatory compliance, and deploy innovative technology solutions.

A few years ago, I noticed a recurring big hairy problem in the life sciences industry: 

(hint: it's not what you think!)

Companies drowning in data but starving for insights.

I saw teams spending countless hours sifting through spreadsheets, chasing down reports, and still missing critical information when it mattered most. 

Compliance felt like a burden rather than a built-in strength.

I knew there had to be a better way.

That's why I founded Qualtivate.

We started with a simple yet powerful idea: 
Integrate quality directly into everyday workflows and technology. 

No more patchwork solutions or endless manual processes. 

Just streamlined, intelligent systems that turn messy, unstructured data into clear, actionable insights.

Today, we've helped 15+ life science companies transform their approach to quality management. 

By automating workflows and connecting systems, we've not only reduced manual efforts by up to 65% (stats collected by QC lead from a top-25 biotech client) but also empowered organizations to make smarter, faster decisions with confidence.

Just imagine having all your critical data at your fingertips, processes that adapt and improve continuously, and a team that's freed up to focus on innovation rather than administration.

That's the future we're building at Qualtivate.

Are you ready to leave outdated practices behind and embrace a smarter approach to quality and compliance?

Let's make it happen together.

👉🏼 Connect with me or visit qualtivate.com to learn how we can elevate your quality management to the next level.

CEO and Founder– Qualtivate 

Qualtivate is a quality management and regulatory compliance consulting firm helping life science companies make data-driven decisions throughout their product development lifecycle.

How?
Cultivate insights from your QMS data in hours, not days using our technical expertise in off-the-shelf no-code, automation and AI/ML tools.

Build your phase-appropriate quality management system (QMS) that:

• Provides full transparency of product data, processes, systems, and people. 
• Automates performance monitoring and quality management reviews.
• Embeds compliance within flexible, user-friendly, organically built processes.
• Reduces the organization's quality costs by automating data collection, analysis, trending, and reporting.

To find out more about how we can help, please get in touch with me directly on the details below. 

☏ +1-919-213-8737
✉ hthakkar@qualtivate.com 	
Visit ☛ www.qualtivate.com

EPM Scientific

- Ensuring compliance with quality requirements for medical devices
- Contact person for customers and suppliers with regard to product quality
- Support the continuous development of quality management systems
- Deviation and change management
- Ensuring product conformity in the event of changes (change control)
- Investigation of product complaints and derivation of suitable measures
- Creation of 8D reports including CAPA's in the system
- CAPA Owner for Assigned Products/Customers
- Creation and coordination of qualification and validation plans for existing and new products, processes, and lines together with customers.
- Implementation of qualifications and Validation
- Planning and implementation of requalification’s and revalidations
- Coordination and implementation of FMEAs
- Statistical analysis of data sets and key figures
- Creation of requirement catalogues, control plans, master validation plans

QA Consultant / PQE at Flex Precision Plastics Solutions AG

 Sabbatical

Aristo AG

•	Ensuring the implementation, monitoring and effective completion of the supplier quality management in accordance with the quality management strategy and requirements.
•	Maintenance and effective execution of the SCAR process in line with established Quality Agreements and product specification. 
•	Establishing, leading and concluding Quality Agreements with suppliers.
•	Conducting the supplier evaluations and qualifications.
•	Supporting and collaborating with cross-functional teams towards the customer complaint reduction plan.
•	Collaborating closely with R&D, operations and purchasing to assess, select and qualify new suppliers and to qualify critical components.
•	Supporting risk assessment for suppliers’ related waiver requests and ensuring proper monitoring to avoid or reduce customer complaints.
•	Monitoring and reporting suppliers’ quality performance to management. Analyzes, defines and drives continuous improvement projects based on top detractors.
•	Supporting Supplier Performance Evaluation jointly with purchasing department. 
•	Supporting supplier audit program in coordination with the SOP and Quality strategy.

QA Consultant / SQE at ACUTRONIC Medical Systems AG, Companies of Vyaire Medical

EPM Scientific - Phaidon International

Head of MRB team
Supplier Auditor
• Ensure externally manufactured products meet EU MDR requirements.
• Support Review and Approval of supplier Process Validation Protocols and Reports as applicable.
• Work with Suppliers to meet EU MDR requirements and resolve issues with obtaining Supplier Product information.
• Support definition and clarification of EU MDR supplier related process requirements.
• Participated Supplier Audit as Co-Auditor

Senior QA Consultant / SQE at VMS iLab, Companies of Siemens Healthineers

• Ensures compliance requirements according to 21CFR part 820, Directive 93/42/EEC, Regulation (EU) 2017/745, ISO 13485, and the company quality manual
• Ensures in close collaboration with design and engineering teams that all product realization processes are applied, and the product is compliant
• Review of the design and development documentation for adequacy and ensures that they are consistent with the company wide global processes
• Supports, evaluates, and monitors that the required verification and validation processes are performed and documented
• Defines and ensures that statistical data is collection and analyses of the statistical data thereafter
• Supports and evaluates engineering teams with the root cause analysis and corrective actions (CAPA) implementation

QA Consultant / RA/QA Specialist at VMS iLab, Companies of Siemens Healthineers

Straub Medical AG, Companies of BD

Documentary rebuild of legacy existing installation qualifications of machinery, equipment and devices. Write log and report from existing data into a new template. Support of retrospective creation of installation qualifications of machines, plants and devices.

QA Consultant / Qualification- and Validation Engineer

MAETRICS

Medical device quality engineer serving Maetrics clients in a variety of aspects relating to Quality Management Systems ISO 9001, ISO 13485 and FDA QSR 820. Specifically focusing on CAPA and NCR’s including remediation and preparation for MDSAP and MDR Audits. Performing of investigations and Root Cause Analysis on Operations related issues.

QA Consultant / Senior Associate

Roche Diagnostics 

•	Creation and rework of production documents
•	Planning, supporting and tracking of process and document changes 
•	Collaboration: creation of validation documents
•	Collaboration: creation of pFMEAS and participation in the pFMEAS sessions
•	Document-management and documentation in SAP

Technical Writer

DePuy Synthes, Companies of Johnson & Johnson

•	Coaching and Support of employees 
•	Steering the creation, modification, distribution / publication and withdrawal of quality management documents
•	Developing and maintaining a consistent and streamlined documentation system structure
•	Ensuring compliance verification of all documents with the current standards and regulations
•	Support the applicant in the preparation of DCR / DCO and in the document changes
•	Support to applicants for new or modified documents, in terms of coverage of the applicable standards and laws

Novawerke AG, 8307 Effretikon

•	Incoming goods inspections
•	Programming / performing and acquiring measurement tests with Zeiss 3D measuring machines
•	Support in the management of test devices and gauges
•	Quality tests with audit reports (internal / external)
•	Ensure processes are followed
•	Supervise internal procedures
•	Inspection reports (ISIR)
•	Test plan creation (AHP)

Messtechniker / Qualitätsprüfer

Kaba

•	Creation of test plans for WEP, ISIR and test                                                                       equipment
•	Calibration of the test equipment
•	Documentation of all tests and processes
•	Responsible for vendor complaints
•	Supplier administration and order tracking
•	Tracking of quality issues and reporting.
•	Planning of the acceptance of process and machine capabilities in machines
•	Coordination of internal audits and reports

Qualitätstechniker QS

Experienced Quality Consultant with a demonstrated history of working in the medical device industry and Pharmacie. Professional skilled in Quality Management  Systems according to ISO 13485 and 21 CFR 820 (FDA). Special focus on CAPAs and NCRs, including remediation, preparation and execution of MDSAP and MDR audits.
Performing of investigations and Root Cause Analysis on Operations related issues.

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