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Suranga Suraweera

@surangasuraweera

Technical Operations executive at BioRestorative Therapies overseeing manufacturing, Quality, and clinical supply readiness for bio-cosmeceutical programs.

United States

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At BioRestorative Therapies, I lead enterprise Technical Operations across Manufacturing, Quality Assurance, Quality Control, Facilities, and Supply Chain. I oversee investigational product release, manufacturing quality, and facility readiness for development-stage bio-cosmeceutical programs.

As Director, Quality & Compliance / Site Head of Quality at BioRestorative Therapies, I led site Quality for Phase 2 cell therapy and preclinical programs. I oversaw Quality through the BRTX-100 Phase 2 manufacturing campaign and implemented in-house mycoplasma testing, reducing batch-record and clinical release cycle time.

At Bristol Myers Squibb, I served as site Business Process Owner and Subject Matter Expert for CAPA, investigations, and proactive Quality initiatives supporting commercial CAR-T products. I led migration of CAPA records into Veeva Vault QMS, completing it one month ahead of the global deadline.

Earlier, at AbbVie and Allergan, I worked across Quality Engineering, human tissue products, risk management, and manufacturing support. At Dendreon Corporation, I performed aseptic cGMP manufacturing of clinical and commercial cellular products and supported scale-up of an autologous cellular therapy from 12 to 48 workstations.

Experience

Work history, roles, and key accomplishments

Current

Vice President, Technical Operations

Current

BioRestorative Therapies

Jul 2026 - Present (3 months)

Leads enterprise Technical Operations across Manufacturing, Quality Assurance, Quality Control, Quality Systems, Facilities, Supply Chain, and clinical/commercial operations. Provides executive oversight of investigational product release, cGMP/cGTP manufacturing quality, and inspection readiness.

Inspection Readiness Manufacturing Quality Assurance Quality Control Quality Systems Facilities Supply Chain Clinical Operations GMP CGTP Aseptic Processing Disposition Validation Risk Management

Director, Quality & Compliance / Site Head of Quality

BioRestorative Therapies

Aug 2024 - Jul 2026 (1 year 11 months)

Led the site Quality and Compliance organization supporting Phase 2 cell therapy, preclinical development, and pre-commercial programs. Managed QA/QC, investigational product disposition, Quality Systems, supplier quality, training, and facility compliance.

QA&QC Quality Systems Supplier Quality Training Facility Compliance Batch Record Review Disposition Management Deviations CAPA Change Control Document Control Release Testing EQMS Veeva Vault Inspection Readiness

Senior Manager, Quality Systems

Bristol Myers Squibb

Nov 2022 - Jul 2024 (1 year 8 months)

Served as site Business Process Owner and Subject Matter Expert for CAPA, effectiveness checks, root cause analysis, and proactive Quality initiatives supporting commercial CAR-T products. Managed QA personnel and facilitated Investigation, CAPA, and Complaint Review Boards.

CAPA Root Cause Analysis EQRMS Veeva Vault Enact (InfinityQS) QMS Quality Systems KPI development Metrics Trending Training Inspection Support

Manager, Quality Engineering

AbbVie

Oct 2019 - Nov 2022 (3 years 1 month)

Led a high-performing Quality Engineering organization partnering with Manufacturing, Planning, Operations, and R&D to resolve product/material disposition, manufacturing, supplier, validation, and cleanroom issues. Provided 24/7 Quality leadership for manufacturing and cleanroom operations.

Quality Engineering CAPA Root Cause Analysis FDA GMP GTP ISO 9001 ISO 13485 ISO 14971 EU MDR USP Clean Room Operation Validation Supplier Quality

Quality Engineer III – Production Support

Allergan (Now AbbVie)

Apr 2018 - Oct 2019 (1 year 6 months)

Led compliance and audit-response activities supporting FDA, MDSAP, DEKRA, and AATB inspections. Developed and authored ad hoc Quality risk assessments, BPDRs, Health Hazard Evaluations, FMECA, hazard analyses, risk registries, market-action, and manufacturing decisions.

Compliance Audit Response FDA MDSAP DEKRA AATB Risk Management FMECA Hazard Assessments CAPA Clean Room Operation

Quality Engineer II – Production Support

LifeCell Corporation (Now AbbVie)

Jan 2016 - Apr 2018 (2 years 3 months)

Provided Quality Engineering oversight for nonconformances, CAPA, supplier change controls, validation, equipment qualification/requalification, calibration, and manufacturing Quality issues. Served as an internal consultant to Manufacturing and cross-functional teams.

Quality Engineering Non Conformities CAPA Supplier Change Control Validation Equipment Qualification Calibration GMP CGTP GDP ISO 13485 ISO 14971

Regulatory / Quality Auditor

LifeCell Corporation (Now AbbVie)

Jan 2013 - Oct 2014 (1 year 9 months)

Conducted internal compliance audits and routine monitoring of production activities, gowning practices, aseptic technique, and manufacturing operations against cGMP requirements and approved procedures. Documented and escalated observations to area leadership.

Compliance Audits GMP Aseptic Technique CAPA Change Control Performance Trends Lean Six Sigma

Principal Investigator – Manufacturing / Quality Investigations

Dendreon Corporation

Jan 2011 - Dec 2012 (1 year 11 months)

Authored, investigated, and approved deviation reports and laboratory OOS investigations within Pilgrim QMS. Authored SOPs, batch records, and test methods and executed validation protocols.

Deviations and Investigations OOS Pilgrim QMS SOPs Batch Records Testing Methodologies Validation Protocols

Cell Processing Associate I & II

Dendreon Corporation

Mar 2010 - Dec 2012 (2 years 9 months)

Performed aseptic cGMP manufacturing of clinical and commercial human prostate cancer cellular products within an ISO 7 cleanroom environment. Supported the clinical-to-commercial transition and manufacturing scale-up of an autologous cellular therapy.

Aseptic Manufacturing Operations GMP ISO7 Clean Room Procedures Cellular Therapy Scale Up Training