ANKITA MODI
Hopkinton,MA
Summary
Well-versed Quality Assurance Proficient with relevant experience in overseeing the production process, identifying and resolving issues, and ensuring products meet company standards. Strengths include strong communication skills, strategic planning abilities, and comprehensive knowledge of various Regulatory guidance. Previous roles highlighted ability to improve quality processes by conducting thorough analysis and implementing effective solutions. Over 14 years of experience in the GxP space, specializing in small molecule and large molecule pharma/biotech industry.
Overview
17
17
years of professional experience
Work History
Associate Director, QA Operations
MorphoSys Inc
Boston, MA
04.2022 - Current
- Efficiently delivered operational support to cross-functional teams in maintaining the quality and compliance of clinical and commercial products according to GMP and GDP regulations, as well as internal policies, procedures, and industry standards.
- Managed and approved clinical and commercial product quality documentation for both large molecule and small molecule materials.
- Successfully reviewed and assessed clinical and commercial product quality events which encompassed deviations, investigations, change controls, product complaints, and CAPAs.
- Supported deviation tracking efforts to ensure timely closure of investigations and CAPAs, while also responsible for drafting biological product deviation reports (BPDR) and Field Alert documentation when required.
- Performed internal and external audits while overseeing the GMP internal audit schedule.
- Wrote and developed GMP Quality Technical Agreements with external CDMOs.
- Managed batch disposal for commercial and clinical batches.
- Maintained relationships with partners, CMOs, and third-party logistics/distribution facilities while supporting technology transfers at CMOs in a Quality role.
- Verified the accuracy of external vendor GMP documents encompassing drug substance and drug product batch records, packaging, and labeling.
- Ensured active participation in both internal and external meetings as a representative for the Quality department.
- Demonstrated expertise in leading health authority inspections as the Quality representative.
- Ensured accuracy of commercial DS and DP PQR/APR.
- Contributed to the management of shipping and transport duties involving validations, qualifications, and the investigation of shipment temperature excursions.
- Ensured accuracy and compliance of commercial and clinical artwork used for labeling purposes.
- Executed updates to Standard Operating Procedures in order to enhance efficiency and productivity through the utilization of Lean Six Sigma principles.
- Contributed to commercial launch readiness efforts through the review of regulatory filing sections for NDA and MAA.
- Consistently maintain and track quality metrics and Key Performance Indicators (KPIs).
Senior Manager, Quality Assurance
Jounce Therapeutics
Cambridge, MA
08.2021 - 04.2022
- Provided oversight and support for QA, CMC operations throughout the end-to-end supply chain.
- Facilitating product-related investigations and verifying compliance with defined quality standards through batch record review.
- Actively participated in cross-functional meetings and projects as the QA representative.
- Implemented quality systems program through the creation of internal trackers and repository folder structure, enabling efficient tracking and archiving of approved documents including change controls, deviations, and CAPAs
- Streamlined document management processes by creating a centralized repository for released lot packets and other approved documents in BOX QA folders
- Maintained and updated employees' training files to ensure compliance with training program requirements.
- Assisted with issuing DCRs, routing new SOPs and/or revisions, and maintaining tracking of numbering system in Excel sheet.
- Managed the creation, assessment, and endorsement of both internal and external documents related to GMP operations including master batch records, stability protocols/reports, specifications, deviations, change controls, temperature excursions.
- Evaluated current internal processes and systems through GAP Analysis, issuing strategic recommendations for enhancement.
- Restructured internal QA SOPs and developed new procedures to enhance the implementation of QA processes.
Manager/Sr. Specialist, GMP QA
Agios Pharmaceuticals
Cambridge, MA
06.2017 - 08.2021
- Conduct activities supporting release of clinical and commercial products across multiple countries, including reviewing batch records, specifications, testing records, COAs, labels, and other relevant documents to ensure accuracy and compliance with standards.
- Organized and coordinated QA operational packaging and labeling resources.
- Ensured accuracy and completeness of Packaging insert content for commercial drug product launch.
- Engaged in various commercial product launch initiatives and simulated PAI audits.
- Collaborated with key stakeholders to develop and implement strategies and plans for drug packaging/labeling, ensuring timely release of investigational products
- Maintained strong partnerships with CMOs, ensuring timely reporting of relevant metrics both internally and externally.
- Reviewed and approved validation protocols/reports for compliance.
- Developed and executed initiatives aimed at continuously improving internal processes and optimizing vendor performance, leading to sustained growth.
- Served as Agios QA representative in external CMOs project teams, facilitating periodic visits for effective vendor management
- Ensured accuracy of Master label and label proofs for clinical IMPs
- Ensured smooth and efficient release of finished goods by monitoring QP activities
- Contributed as part of an internal multidisciplinary team to support packaging/labeling, testing, and product complaint investigations
- Oversaw the management and resolution of investigations along with handling CAPAs, change controls,OOS issues and Material Review Board processes.
- Contributed to improving cGMP-related Quality Key Performance Indicators (KPIs) through participation in Quality metrics, reports, reviews, and trends.
- Conducted comprehensive Quality Agreement reviews and implemented necessary improvements for enhanced performance
- Contributed to the preparation and review of CMC sections in regulatory submissions including INDs, NDAs, MAAs, and IMPDs.
- Responsible for auditing CMOs and ID Testing Laboratories, compiling detailed reports.
- Supported quality assurance activities during regulatory inspections.
- Facilitated communication between external partners and internal teams for seamless coordination of manufacturing, testing, and stability studies.
- Assisted in the improvement of Agios' quality systems by offering QA support, developing new processes, and enhancing existing procedures.
QA Specialist II, Lot review
Lonza Biologics Inc.
Portsmouth, NH
03.2016 - 06.2017
- Conduct comprehensive review of batch records to ensure cGMP compliance according to written procedures.
- Conducted analysis of manufacturing logbooks and QC assays.
- Demonstrated working knowledge of quality systems, including deviations, CAPA, document change, and process change procedures to ensure adherence to required protocols.
- Maintained adherence to review and release schedule by compiling batch documentation for lot release in a timely manner.
- Confirmed completion of necessary event closures before releasing lots.
- Generated concise responses for customer review observations.
- Delivered ongoing cGMP manufacturing review training courses.
- Assisted with various departmental assignments.
Quality Assurance Specialist
SEQENS (formerly, PCI Synthesis)
Newburyport, MA
10.2011 - 02.2016
- Demonstrated comprehensive working knowledge of 21 CFR 211 and ICH Q7 while actively participating in Quality Assurance duties following current Good Manufacturing Practices.
- Prepared comprehensive Annual product review reports for commercial APIs and assisted in filing drug master files to support the regulatory team.
- Contributed to numerous External Audits for supplier qualification program.
- Conducted in-depth investigations into customer complaints and nonconformance issues.
- Ensured continuous adherence to quality and industry regulatory standards.
- Provided quality assurance support for plant validation, engineering activities and transition of technology from R&D to manufacturing.
- Evaluated investigations and delegated appropriate corrective and preventive actions.
- Contributed to change control procedures by implementing documentation, equipment, and process changes.
- Ensured adherence to the Quality Program and cGMP standards through diligent execution of internal audits and production of detailed audit reports.
- Developed and executed training programs for manufacturing and QC teams, improving overall compliance with quality standards.
- Conducted comprehensive assessments of product labeling, batch records, analytical testing, and release specifications to verify adherence to regulatory requirements.
- Generated SOP updates, work instructions, and policies to ensure smooth operations.
Quality Control Analyst
SEQENS (formerly, PCI Synthesis)
Newburyport, MA
11.2010 - 09.2011
- Conducted routine and non-routine analyses of various samples including in-process materials, raw materials, environmental samples, finished goods, and stability samples
- Analyzed test results, comparing them to set specifications and control limits, and advised on the suitability of data for approval.
- Performed calibration of various laboratory equipment like HPLC, GC, UV, FTIR, KF, TOC along with particle size analyzer and analytical balance on schedule
- Engaged in investigations of out-of-specification and failure incidents, providing recommendations for corrective measures
- Ensured adherence to lab cleanliness and safety standards
- Authored technical documentation comprising of deviation reports, testing protocols, and trend analyses
- Oversaw the collaboration with contract laboratories and external vendors for testing purposes.
- Performed troubleshooting on applicable laboratory equipment when necessary.
- Engaged in regular participation in internal assessments and audits when required.
- Enhanced efficiency by revising and streamlining quality control protocols.
Internship in Quality department
Sarabhai Chemicals
Vadodara, India
05.2007 - 12.2007
- Executed quality control tests to evaluate the adequacy of in-process and finished products according to cGMP guidelines.
- Utilized HPLC, TLC, GC, and UV spectrophotometer to purify and separate samples through analytical techniques.
- Assessed accuracy of analytical data and batch record.
- Authored change control and investigation reports as required.
Education
Master of Science - Industrial Pharmacy
St. John's University
Queens, NY05-2010
Bachelor of Pharmacy - Pharmacy
Veer Narmad South Gujarat University
Bardoli, India06-2007
Skills
- Product Release
- Quality Inspection
- Six Sigma Methodologies
- Cross-Functional Teamwork
- Deviations, Change controls, Complaints, Recalls and CAPAs
- External Audits
- SOP Writing
- Process Improvement
- Quality Management Systems
(VeevaVault, ComplianceWire, TrackWise & QCBD)
- Project Management
- Team Leadership
- Decision-Making
- Technical Documentation/reports
- Regulatory Guidance
(FDA, EMA, ICH, Health Canada and China)
Timeline
Associate Director, QA Operations
MorphoSys Inc
04.2022 - Current
Senior Manager, Quality Assurance
Jounce Therapeutics
08.2021 - 04.2022
Manager/Sr. Specialist, GMP QA
Agios Pharmaceuticals
06.2017 - 08.2021
QA Specialist II, Lot review
Lonza Biologics Inc.
03.2016 - 06.2017
Quality Assurance Specialist
SEQENS (formerly, PCI Synthesis)
10.2011 - 02.2016
Quality Control Analyst
SEQENS (formerly, PCI Synthesis)
11.2010 - 09.2011
Internship in Quality department
Sarabhai Chemicals
05.2007 - 12.2007
Master of Science - Industrial Pharmacy
St. John's University
Bachelor of Pharmacy - Pharmacy
Veer Narmad South Gujarat University
Similar Profiles
Shannon FitzgeraldShannon Fitzgerald
Oncology Account Manager at MorphosysOncology Account Manager at Morphosys
Fabrice Tiba, PhDFabrice Tiba, PhD
Medical Reserach Clinical Advisor at The Medical Affairs Compant / Morphosys AGMedical Reserach Clinical Advisor at The Medical Affairs Compant / Morphosys AG
Lynda Davern ZegersLynda Davern Zegers
ONCOLOGY ACCOUNT MANAGER at MorphosysONCOLOGY ACCOUNT MANAGER at Morphosys