QA Manager, Clinical Research

Groom & Associates; Montreal; On-site; CAD 60,000 - 80,000; Full time

Job summary

A leading global provider of quality solutions is seeking a QA Manager for Clinical Research in Montreal. This key role involves ensuring compliance with GCP, GDPR, and GAMP5 regulations, managing audits, and overseeing the Quality Management System. The ideal candidate will have a Master's degree in Health Sciences and at least 4 years of relevant experience. Join a team committed to advancing healthcare globally.

Qualifications

• Minimum of 4 years of experience as a QA Manager or in a similar role.
• In-depth knowledge of GCP, GDPR, and GAMP5 regulations.
• Proven experience in managing internal and external audits.

Responsibilities

• Implement and enhance quality policies in compliance with regulations.
• Supervise the Quality Management System for clinical research activities.
• Conduct and document internal and supplier audits.
• Oversee client audits and regulatory inspections.
• Identify and manage risks related to clinical research.

Skills

GCP knowledge

Regulatory compliance

Audit management

Quality management standards

Data analysis

Education

Master's degree in Health Sciences or related field

Tools

Computerized data management tools

Job description

Job Number : J0525-0218 Job Type : Full Time Job Category : Management / Leadership Salary : Open

QA Manager, Clinical Research

Position : QA Manager, Clinical Research

Location : Montreal, Canada

Department : Quality & Regulatory

Reporting to : Quality Director & DPO

Company Overview :

Our client is a leading global provider of Cardiac Safety, Central Imaging, Endpoint Adjudication, and eCOA solutions, serving pharmaceutical, medical device, and biotech companies, CROs, and nonprofit organizations. With a strong commitment to quality and innovation, they play a pivotal role in supporting clinical trials from early to late-stage development. Operating internationally, their team is driven by excellence, ethical standards, and a shared mission to advance healthcare globally.

Role Overview :

The QA Manager, Clinical Research is a key role responsible for ensuring the quality, compliance, and safety of clinical trials. The successful candidate will oversee processes to meet regulatory requirements, including Good Clinical Practice (GCP), General Data Protection Regulation (GDPR), and Good Automated Manufacturing Practice (GAMP5). This position is critical in maintaining data reliability, protecting patient rights, and fostering stakeholder confidence.

Key Responsibilities :

• Implement, monitor, and enhance the quality policy in compliance with regulatory frameworks.
• Supervise the Quality Management System (QMS) for clinical research activities and optimize processes.
• Conduct regulatory monitoring and impact assessments.
• Plan, conduct, and document internal and supplier audits, ensuring compliance with regulatory requirements.
• Oversee client audits and regulatory inspections.
• Respond to client qualification questionnaires.
• Collaborate with operational teams to ensure the quality of activities, data, and services.
• Identify, assess, and manage risks related to clinical research activities.
• Provide training and awareness programs for staff on quality and regulatory requirements (QMS, GCP, GDPR, etc.).
• Monitor performance metrics and report findings to senior management.
• Track client and stakeholder satisfaction and suggest improvements.

Qualifications and Experience :

Master's degree (Bac+5) in Health Sciences, Life Sciences, Pharmacy, Quality, or a related field.

Minimum of 4 years of experience as a QA Manager or in a similar role within clinical research.

In-depth knowledge of GCP, GDPR, and GAMP5 regulations.

Proven experience in managing internal and external audits.

Core Competencies :

Technical Knowledge :

Strong understanding of quality management standards (ISO 9001, ISO 9000).

Expertise in clinical research regulations (GCP, ICH E6, ICH E14).

Familiarity with GDPR, data privacy principles, ALCOA++, and 21 CFR Part 11.

Knowledge of computerized system validation requirements (EMA guidelines, GAMP5).

Risk management, medical device vigilance, and pharmacovigilance experience.

Comprehensive understanding of clinical research processes.

Technical Skills :

Ability to assess compliance with procedures and quality documentation.

Planning and conducting audits with a factual, unbiased approach.

Data analysis and synthesis of performance indicators.

Proficiency in computerized data management tools.

Identifying and addressing process deficiencies and implementing corrective actions.

Strong communication and training skills.

Soft Skills :

Strong organizational and planning abilities.

Rigorous and methodical approach.

Analytical and observational skills.

Critical thinking and problem-solving mindset.

Strong ethical standards and confidentiality awareness.

Excellent interpersonal and teamwork skills.

Adaptability and responsiveness.

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