Gxp Product Owner, Sr. Business Analyst, Cell Therapies Manufacturing Facility
Current
Oct 2024 - Present
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Priyanka Gugulothu Email & Phone Number
GxP Product Owner, Sr. Business Analyst, Cell Therapies Manufacturing Facility
at
Takeda
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✓ Verified Jun 2026
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Profile completeness 86%
Current company
Role
GxP Product Owner, Sr. Business Analyst, Cell Therapies Manufacturing Facility
Location
North York, Ontario, Canada
Company size
Who is Priyanka Gugulothu? Overview
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Quick answer
Priyanka Gugulothu is listed as GxP Product Owner, Sr. Business Analyst, Cell Therapies Manufacturing Facility at Takeda, a company with 32621 employees, based in North York, Ontario, Canada. AeroLeads shows a matched LinkedIn profile for Priyanka Gugulothu.
Priyanka Gugulothu previously worked as President at Priva Consulting Inc. and Senior Business Analyst, GxP Document Specialist at Kalleid. Priyanka Gugulothu holds Master'S Degree, Biotechnology from New York University.
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Takeda
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Profile bio
About Priyanka Gugulothu
My education in life sciences has nurtured a profound and deep-rooted vigilance for the quality of care, treatment, and medical devices that have the ability to impact millions of patients each day. My goal is to continue in the path of CSV and be a valuable member of the Pharmaceutical, Biotechnology and Healthcare Industry to deliver Quality and Compliance above all.I have grown consistently, starting out as a technical writer and validation engineer for a major pharmaceutical company to becoming a stand-alone quality manager for a small biotechnology solutions company and applying my skills to create a QMS and submitting to an external vendor SQA audit with great success, leading to product certification and sales. Following this stint, I continued as a Project Quality and Validation Manager as well as Quality Trainer at the pharmaceutical company, providing guidance and working actively with GxP Computerized Systems Validation.I am a self-starting, highly independent, and confident professional with excellent work ethic and an appetite for learning. I bring a can-do attitude and highly approachable demeanor to the workplace. I have worked equally well with large and small teams to make projects of all sizes a great success.Expertise includes:‣ 9+ years of experience with producing Quality deliverables for GxP computerized systems. Proficient in authoring Validation Protocols, Validation Summary Reports, and Test Plans, Test Procedures, Test Results, User Requirement Specifications, Functional Requirements Specification, and Design Specifications. ‣ 9+ years of experience with Deviation Management and CAPA and engineering deviation resolution. Skilled in carrying out Gap Analysis and performing Remediation Planning. ‣ 7+ years of training personnel in Good Documentation Practices and Validation Testing best practices. ‣ 6+ years of experience with Novartis ICE Project Management Methodology and ICE Silver level certification. Excellent understanding of Software Development Lifecycle (SDLC). ‣ Expert knowledge of 21 CFR Part 11, Data Integrity, and GxP Risk Assessment.
Current workplace
Priyanka Gugulothu's current company
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Takeda
11 roles
Priyanka Gugulothu work experience
A career timeline built from the work history available for this profile.
President
Provides ad hoc consulting for Pharma and Biotech clients in:✓ Computer System Validation and Testing of GxP Systems✓ Business Analysis, requirements gathering, and documentation✓ UAT script writing and execution✓ Training design and delivery on Testing, Validation Best Practices, Good Documentation Practices✓ Technical Writing, SOP Writing
Senior Business Analyst, Gxp Document Specialist
Senior Validation Consultant
Key Contributions:✓ Created complete Validation packages for two (2) distinct offerings of their Clinical Supply Chain Commercial Off-the-Shelf products.✓ Provided complete guidance on Validation execution.
Oct 2023 - Oct 2024
Gxp Csc Documentation Consultant
Key Contributions:✓ As the lead GxP documentation specialist for the Clinical Supply Chain (CSC) process, responsible for swarming the business processes and 100+ SOPs related to the legacy CSC system and updating them for the new PMD system being implemented globally in the USA and UK.✓ Created new SOPs for the global PMD system to account for brand new.
Mar 2022 - Oct 2024
Product Owner, Sr. Business Analyst, Cell Therapies Manufacturing Facility
Key Contributions:✓ Product owner and senior business analyst of various IT Lab and Enterprise systems for the Cell Therapies Manufacturing Facility (CTMF).✓ Responsible for productization and implementing Agile Methodology for previously waterfall systems. ✓ Responsible for Validation of Lab and Enterprise systems. Responsible for periodic reviews of Lab.
Nov 2022 - Sep 2023
Documentation Specialist
Key Contributions:✓ Interviewed 30+ lab personnel from finance to decommissioning to write a white paper titled "A Modern Framework for Integrated Laboratory Instrument Management (LIM)” which was presented by the client at the SLAS 2023 Conference in Boston.✓ Creating a new foundry catalog for all the services offered internally by Ginkgo Bioworks and.
Jun 2022 - Jan 2023
Business Analyst, Lead Business Analyst For Qms
Key Contributions:✓ Supported implementations of the Xybion CQRM system globally (at the time focusing support on Germany and the USA).✓ Understood the CQRM business requirements, created workflows, understood methods, created user and functional requirements to meet the business needs as part of client projects.✓ Brainstormed design with the development.
Nov 2021 - Feb 2022
Sr. Consultant, Csv, Lead Validation Manager
CLIENT: Novartis Services Inc., Alcon Division (Texas, USA)As the Sr. Consultant, CSV, I was responsible for managing validation of multi-year global warehouse management system projects (net new implementation, upgrade, and SAP integration.✓ Lead large global cross-functional teams including IT, Business, Infrastructure Services.✓ Ensured and managed.
Oct 2016 - Nov 2021
Qa And Validation Manager
Validation Associates Llc
CLIENT: Spectra Automation (Massachusetts, USA)✓ Established a Quality Management System based on ISO 9001:2008 standards✓ Authored all the quality related Standard Operating Procedures like Document Control and Management Procedure, Software Change Control procedure, Incident Management procedures, Master Validation Plan, Quality Manual, Quality Policy.
Apr 2016 - Sep 2016
Validation Engineer
Validation Associates Llc
CLIENT: Novartis Services Inc., Alcon Division (Texas, USA)Provided direct professional expertise to the Project Manager and various departments on company operations through the following:✓ Created Capital Appropriations Request and Project Charter✓ Developed Test Scripts for Operational Qualification and Peer Reviewing OQ/PQs✓ Created Tollgate Reports.
Mar 2015 - Mar 2016
Team & coworkers
Colleagues at Takeda
Other employees you can reach at takeda.com. View company contacts for 32621 employees →
OI
Olena Ivannykova
Colleague at TakedaKyiv, Kyiv City, Ukraine, Ukraine
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AU
Ayse Uysal Torun
Colleague at TakedaTürkiye, Turkey
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GA
Golrou Abdollahi
Colleague at TakedaZurich, Zurich, Switzerland, Switzerland
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AR
Aurelien Roland
Colleague at TakedaCharleroi Metropolitan Area, Belgium
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PM
Peter Mwangi
Colleague at TakedaKenya, Kenya
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AH
Alexis Hazel
Colleague at TakedaAlexander, North Dakota, United States, United States
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DK
Dana King
Colleague at TakedaDeerfield, Illinois, United States, United States
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TM
Tom Mangen
Colleague at TakedaVienna, Vienna, Austria, Austria
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MM
Marek Macko
Colleague at TakedaIreland, Ireland
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HB
Hreetesh Bhandari
Colleague at TakedaDelhi, India, India
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Olena Ivannykova
Colleague at TakedaKyiv, Kyiv City, Ukraine, Ukraine
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AU
Ayse Uysal Torun
Colleague at TakedaTürkiye, Turkey
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GA
Golrou Abdollahi
Colleague at TakedaZurich, Zurich, Switzerland, Switzerland
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AR
Aurelien Roland
Colleague at TakedaCharleroi Metropolitan Area, Belgium
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PM
Peter Mwangi
Colleague at TakedaKenya, Kenya
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AH
Alexis Hazel
Colleague at TakedaAlexander, North Dakota, United States, United States
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DK
Dana King
Colleague at TakedaDeerfield, Illinois, United States, United States
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TM
Tom Mangen
Colleague at TakedaVienna, Vienna, Austria, Austria
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MM
Marek Macko
Colleague at TakedaIreland, Ireland
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HB
Hreetesh Bhandari
Colleague at TakedaDelhi, India, India
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2 education records
Priyanka Gugulothu education
Master'S Degree, Biotechnology
Bachelor Of Technology - Btech, Biotechnology
FAQ
Frequently asked questions about Priyanka Gugulothu
Quick answers generated from the profile data available on this page.
What company does Priyanka Gugulothu work for?
Priyanka Gugulothu works for Takeda.
What is Priyanka Gugulothu's role at Takeda?
Priyanka Gugulothu is listed as GxP Product Owner, Sr. Business Analyst, Cell Therapies Manufacturing Facility at Takeda.
Where is Priyanka Gugulothu based?
Priyanka Gugulothu is based in North York, Ontario, Canada while working with Takeda.
What companies has Priyanka Gugulothu worked for?
Priyanka Gugulothu has worked for Takeda, Priva Consulting Inc., Kalleid, Signant Health, and Gsk.
Who are Priyanka Gugulothu's colleagues at Takeda?
Priyanka Gugulothu's colleagues at Takeda include Olena Ivannykova, Ayse Uysal Torun, Golrou Abdollahi, Aurelien Roland, and Peter Mwangi.
How can I contact Priyanka Gugulothu?
You can use AeroLeads to view verified contact signals for Priyanka Gugulothu at Takeda, including work email, phone, and LinkedIn data when available.
What schools did Priyanka Gugulothu attend?
Priyanka Gugulothu holds Master'S Degree, Biotechnology from New York University.
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