Summary
Overview
Work History
Education
Skills
Certification
References
Affiliations
Training
Timeline
Generic

SHARMILA DORAIRAJ

THORNHILL,CANADA

Summary

Pharmaceutical leader with over 20 years of expertise in GMP, GLP, GCP, ISO 9001, and ISO 13485. Proven track record in implementing Quality Management Systems and ensuring regulatory compliance. Skilled in managing audits, conducting inspections, and leading training initiatives to support organizational growth. Focused on cultivating best practices to meet complex regulatory expectations and enhance client relationships.

Overview

22
22
years of professional experience
1
1
Certification

Work History

Consultant - Good Manufacturing Practices (GMPs), Current GMP (cGMPs), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), ISO, 21 CFR Part 58 and Part 11 Compliance and related regulations.

Ardent-Consultants Inc.
Brampton, ON
10.2023 - Current
  • Manage company policies and ensure compliance with local and international regulations for Medical Devices, Drugs, Nutraceuticals, Natural Health Products, and Cosmetics.
  • Provide expert guidance to clients on quality initiatives, leveraging deep knowledge of regulatory requirements and industry best practices to address specialized tasks.
  • Quality and Regulatory Solutions: Deliver comprehensive quality and regulatory compliance solutions tailored to client needs, from backlog alleviation to long-term strategic support.
  • Audits: Lead audit preparedness and response efforts, including regulatory remediation and managing both internal self-inspections and external customer/vendor audits.
  • SOP Management: Conduct SOP lifecycle management—performing gap analyses, creating and revising SOPs, maintaining distribution control, and developing training quizzes aligned with regulatory expectations.

Associate Director, Quality Assurance - eClinical Suite - eTMF, CTMs, EDC, ePRO, RTSM, Reporting & Safety

Axiom Real-time Metrics
Mississauga, ON
09.2020 - 09.2023
  • Oversaw the design, implementation, and continuous improvement of Axiom’s GCP (Good Clinical Practice) and ISO-compliant Quality Management System (QMS).
  • Proactively updated procedures, conducted training, and led audits to ensure QMS effectiveness.
  • Collaborated closely with cross-functional teams to drive ongoing improvements, supporting the company’s rapid growth.
  • Team Supervision: Grew and led a quality team from 5 to 13, overseeing Documentation Control & Training, audits (supplier, internal), CAPAs, deviations, and quality / compliance functions.
  • Metrics & KPI Development: Developed and reported quality metrics and KPIs, refining frameworks to align with organizational goals and drive performance.
  • Continuous Process Improvement: Led the design, development, and implementation of quality systems, including SOPs, training, work instructions, policies, and regulatory compliance, to enhance efficiency and productivity.
  • Strategic Support: Provided problem-solving and growth-oriented solutions, influencing organizational development and improving quality outcomes.
  • Personnel Empowerment: Conducted performance assessments, recommended promotions and salary adjustments, identified corrective actions, and supported team professional growth.
  • Customer Quality Functions: Led complaint management teams to drive continuous improvement in external Quality Core Value Drivers.
  • Field Action Execution: Directed and coordinated field actions, collaborating with regional teams to track and verify effectiveness.
  • Process Standardization: Drove the standardization and optimization of quality and regulatory processes in collaboration with leadership and cross-functional teams.

Director, Quality Assurance & Regulatory Affairs - Pharmaceutical company

SEAFORD PHARMACEUTICALS INC.
Mississauga, ON
05.2017 - 07.2020
  • Ensured GMP-compliant manufacturing, storage, and distribution of high-quality Drugs, Natural Health Products, Nutraceuticals and Cosmetics, both domestically and internationally.
  • Oversaw compliance with GVP (Good Pharmacovigilance Practices) standards to ensure product safety and regulatory adherence.
  • Managed Drug Establishment and Site Licences for Seaford’s warehouses, ensuring ongoing compliance with industry regulations.

Quality Assurance Specialist– Health Care Logistics (3PL Pharmaceutical Warehousing)

ACCURISTIX
Vaughan, ON
09.2016 - 04.2017
  • Managed multiple client accounts, ensuring the secure, efficient, and GMP-compliant importation, storage, packaging, and distribution of pharmaceuticals, controlled drugs, food, and cosmetics across Canada.
  • Collaborated with internal teams, pharmaceutical/food/cosmetic clients, and transportation partners to meet regulatory and operational requirements.
  • Ensured the compliant handling and transportation of high-value, life-saving products worth over $30 million, delivering accuracy and speed in a high-volume, high-pressure environment.

Technologist / Manager Support – Contract - Diphtheria, Tetanus & PPD Bulk Vaccine Manufacturing

SANOFI PASTEUR
Toronto, ON
07.2015 - 08.2016
  • Supported the Deputy Director in overseeing compliance for Diphtheria, Tetanus, and PPD Bulk Vaccine manufacturing processes (upstream and downstream).
  • Ensured adherence to local and international regulatory guidelines, site policies, and industry best practices across cross-functional teams.
  • Independently reviewed and approved 150+ logs in upstream and downstream processes, ensuring compliance with SOPs.
  • Coordinated with staff to communicate deviations, initiated investigations, and worked closely with quality personnel for resolution.

Quality Assurance and Regulatory Affairs-Associate / Account Manager-Consulting

Eurofins Biopharma (previously Experm Laboratories)
Toronto, ON
06.2014 - 06.2015
  • Managed multiple client accounts, providing comprehensive Quality Assurance, Quality Control, and Regulatory Affairs solutions, along with technical support for pharmaceutical clients worldwide.
  • Applied extensive expertise in GMP/cGMP/GVP/GPP processes to ensure compliance with Health Canada and FDA regulations for Life Sciences, Pharmaceutical, Cosmetic, Medical Device, and Medical Marijuana clients.

Senior Inspector Quality Assurance and Regulatory Affairs (GLP/GCP/GMP)-CRO-Nonclinical & Clinical (Phase I)

CHARLES RIVER LABORATORIES
Montreal, QC
07.2003 - 05.2014
  • Managed nonclinical and Phase I clinical studies for leading global pharmaceutical, biotechnology, agrochemical, government, and academic organizations.
  • Conducted thorough audits of records, protocols, reports, and facilities, ensuring compliance with FDA (21 CFR Part 58, 11, 210-211), EMEA, JMHLW, ICH guidelines, and international regulations.
  • Performed study monitoring and audits to verify regulatory compliance (FDA 21 CFR Part 58 GLP, OECD, EMEA, JMHLW) and adherence to protocols, driving client success.

QA Manager – Medical Marijuana Licensing & Manufacturing

THC Meds Ontario Inc
Uxbridge, ON
07.2015
  • Collaborate with SPIC and A/RPIC: Work closely with SPIC and A/RPIC teams to support licensing, development, and maintenance of critical quality documentation for medical marijuana.
  • SOP Development & Compliance: Draft, review, and update Standard Operating Procedures (SOPs) to ensure alignment with regulatory requirements.
  • QA & Compliance Oversight: Manage all Quality Assurance and compliance operations within a licensed cannabis cultivation facility post-licensure.

Education

Mini-MBA: Essentials of Management - Management And Strategy

Schulich ExecEd | Schulich School of Business | York University
Toronto, ON
09-2024

Bachelor of Science - Biotechnology, Honours

University of Wollongong
Australia

Skills

  • Proven leader in managing regulatory inspections across pharmaceuticals, nutraceuticals, biologics, NHPs, cosmetics, and medical cannabis
  • Deep expertise in GxP regulatory standards including Health Canada, FDA (21 CFR Parts 11, 58, 210–211), EMA, OECD and ICH guidelines, ISO 9001, ISO 13485, GDPR, HIPAA, and JMHLW
  • Skilled in establishing and maintaining Site / Establishment Licences, Product Licences, QMS, SOPs, deviations, CAPAs, change control, complaints, product recalls, validations, continuous improvement and pharmacovigilance
  • Strategic regulatory contributor across product lifecycle from development to post-market updates
  • Proficient in vendor and third-party management to ensure quality and compliance
  • Hands-on experience with project management and quality systems software including MS Project, SAP, QeDoc, Trackwise, Qualio, Empower, Watson, and LIMS
  • Recent Schulich Mini-MBA graduate, strong business and operational acumen
  • Former member of Consumer Health Products Canada; past elected Board Member, Society of Quality Assurance (Canadian Chapter)

Certification

  • GCP for Clinical Investigational Drugs and Biologics (ICH Focus) - CITI Program - Expires Feb 2024
  • GCP for Clinical Investigations of Devices - CITI Program - Expires Feb 2024
  • ISO 14001:2015 - The Aspects and Impacts on Environmental Management System
  • ISO 9001:2015 Requirements (Training Provider & Examiner Certification Scheme) Industry provided GMP Certification & Training
  • Introduction to Regulatory Affairs Level I (96%) | Academy of Applied Pharmaceutical Sciences
  • Registered Quality Assurance Professional in Good Laboratory Practice (RQAP-GLP) certification | Society of Quality Assurance

References

References available upon request.

Affiliations

  • Past Board Member, Canadian Chapter, Society of Quality Assurance
  • Past Member, Society of Quality Assurance
  • Past Active Member, Consumer Health Products Canada
  • Past Active Member, Canadian Association of Professionals in Regulatory Affairs (CAPRA)

Training

  • CHP Canada Product Quality Sub-Committee bilateral meeting with Health Canada (RORB)
  • Canadian Association of Professionals in Regulatory Affairs-CAPRA Education
  • CCSQA (Canadian Chapter for the Society of Quality Assurance) annual meetings
  • PSG 1-day workshop “A Day with the Inspectors (Health Canada)”
  • Various Health Canada Webinars
  • Pharmaceutical Advertising Advisory Board (PAAB) Workshop & Training
  • IQVIA Life Science Symposium
  • WHMIS training

Timeline

Consultant - Good Manufacturing Practices (GMPs), Current GMP (cGMPs), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), ISO, 21 CFR Part 58 and Part 11 Compliance and related regulations.

Ardent-Consultants Inc.
10.2023 - Current

Associate Director, Quality Assurance - eClinical Suite - eTMF, CTMs, EDC, ePRO, RTSM, Reporting & Safety

Axiom Real-time Metrics
09.2020 - 09.2023

Director, Quality Assurance & Regulatory Affairs - Pharmaceutical company

SEAFORD PHARMACEUTICALS INC.
05.2017 - 07.2020

Quality Assurance Specialist– Health Care Logistics (3PL Pharmaceutical Warehousing)

ACCURISTIX
09.2016 - 04.2017

Technologist / Manager Support – Contract - Diphtheria, Tetanus & PPD Bulk Vaccine Manufacturing

SANOFI PASTEUR
07.2015 - 08.2016

QA Manager – Medical Marijuana Licensing & Manufacturing

THC Meds Ontario Inc
07.2015

Quality Assurance and Regulatory Affairs-Associate / Account Manager-Consulting

Eurofins Biopharma (previously Experm Laboratories)
06.2014 - 06.2015

Senior Inspector Quality Assurance and Regulatory Affairs (GLP/GCP/GMP)-CRO-Nonclinical & Clinical (Phase I)

CHARLES RIVER LABORATORIES
07.2003 - 05.2014

Mini-MBA: Essentials of Management - Management And Strategy

Schulich ExecEd | Schulich School of Business | York University

Bachelor of Science - Biotechnology, Honours

University of Wollongong

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SHARMILA DORAIRAJ