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RQC

Quality Consultant

Toronto, ON, Canada
Greater Toronto and Hamilton Area, ON, Canada

Full-time

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Job details

Job type: Full-time
Apply by: Nov 25, 2026
Posting language: English
Posted: Oct 26, 2026

Original job description

The Quality Consultant is responsible for supplying establishment, validation, operational and other quality assurance consulting services to regulated industries, including those in the international Medicinal Product, drug, medical devices, and natural health products spaces.

Responsibilities include:

· Applying your scientific and regulated product knowledge to fulfill client projects, either remotely, or onsite

· Lifecycle management of pharmaceutical quality systems, including management of customer quality manuals and product documentation

· Qualification and validation of facilities, equipment and computerized systems

· Conducting supplier quality and GMP evidence audits

· Authoring and executing compliance approaches for site licensing or remediation.

· Hands-on application and management of quality tasks, at all stages of the drug manufacturing and supply lifecycle, with a focus on:

o Quality risk management

o Product quality system documentation

o Product disposition

o Equipment and process validation

o Electronic systems validation and governance

o Post-market product related activities (e.g., Stability and Annual product review, trending)

o Root cause investigation management

o Reporting and management review functions

o Corrective Action management

o Change management (including risk assessment)

o Analytical test validation and result review

o Quality document review and approval

o Regulatory authority audit hosting

o Product quality complaints

o Annual product quality review, trending and stability performance review

Skills and Job-Related Experience:

· Sound knowledge of quality assurance terminology, International and Health Canada Good Manufacturing Practices (GMPs)

· Demonstrated experience applying quality standards, including good manufacturing practices (GMP), good laboratory practices (GLP), good distribution practices (GDP) and as applicable good clinical practices (GCP)

· Awareness and experience in developing specified quality system components, such as a quality manual, site master file and validation master plan

· Communicate technical information effectively to peers, management, customers using language, graphics, and computer skills.

· Strong organizational and time management skills, combined with a proven ability to meet strict and established timelines.

· Strong problem-solving skills

· Strong written and oral interpersonal and communication skills

· Other language skills are an asset

· Capacity for pharmacovigilance activities an asset

· Knowledge in interpretation of regulations, labelling reviews, compiling regulatory eCTD submissions (drug identification number – DIN), drug establishment licence (DEL), new drug submission (NDS) is an asset

Educational Requirements:

· Post Secondary Quality Assurance and/or Regulatory required (University Degree and/or College Diploma/Certificate or equivalent experience).

· Areas of Specialization: Quality Assurance, regulatory affairs, cannabis, scientific/pharmaceutical industries

Apply About employer

More about this job

Responsibilities

Provide quality assurance consulting to regulated pharmaceutical, medical device, and natural health product industries, including quality system lifecycle management, validation, audits, and regulatory compliance support. Manage quality activities across the product lifecycle, including risk management, documentation, product disposition, investigations, corrective actions, complaints, and post-market reviews.

Requirements

Requires post-secondary education in quality assurance or regulatory affairs, or equivalent experience, and demonstrated experience applying relevant GMP, GLP, GDP, and, where applicable, GCP standards. Candidates should have strong regulatory and quality-system knowledge, communication, organization, time management, and problem-solving skills; experience with quality system documents is expected, while pharmacovigilance and regulatory submissions are assets.

Skills

Quality Assurance
Good Manufacturing Practices (GMP)
Good Laboratory Practices (GLP)
Good Clinical Practices (GCP)
Pharmaceutical Quality Systems
Quality Risk Management
Equipment and Process Validation
Computerized Systems Validation
Supplier Audits
Regulatory Compliance
Root Cause Investigation
Corrective Action Management
Change Management
Pharmacovigilance
Regulatory Submissions

Visa sponsorship

Not detected in the job text

Keywords

Quality Assurance
Regulatory Affairs
Pharmaceutical Manufacturing
Medicinal Products
Medical Devices
Natural Health Products
Good Manufacturing Practices (GMP)
Good Laboratory Practices (GLP)
Good Clinical Practices (GCP)
Quality Manual
Site Master File
Validation Master Plan
Quality Risk Management
Equipment Qualification
Process Validation
Computerized Systems Validation
Electronic Systems Governance
Supplier Quality Audits
Root Cause Investigation
Corrective Actions
Change Management
Product Quality Complaints
Stability Review
Annual Product Quality Review
Pharmacovigilance
Regulatory Authority Audits
Electronic Common Technical Document (eCTD)

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