Quality Assurance Compliance Specialist

Barrington James; Ontario; Remote; CAD 60,000 - 90,000; Full time

Job summary

A dynamic clinical research organisation is seeking a Quality Assurance & Compliance Specialist to support its Quality Management System. This role involves maintaining quality standards, conducting audits, and ensuring regulatory compliance, requiring strong attention to detail and effective communication skills.

Qualifications

• 3+ years in quality assurance or regulatory compliance.
• Solid understanding of ICH-GCP, Health Canada Division 5, and FDA regulations.
• Excellent written and verbal communication skills in English.

Responsibilities

• Maintain and manage the QMS, including SOPs and training files.
• Conduct internal QC audits and manage CAPAs.
• Provide training on Quality System requirements.

Skills

Attention to detail

Time management

Communication skills

Team collaboration

Job description

• 3+ years in a quality assurance or regulatory compliance role within the clinical research , pharmaceutical , biotechnology , or life sciences industry.

Quality Assurance (QA) & Compliance Specialist

Location : Remote or Office-Based (as applicable)

A dynamic and forward-thinking clinical research organisation is seeking a Quality Assurance & Compliance Specialist to support the maintenance and continuous improvement of its Quality Management System (QMS). The organisation provides full-service clinical trial management support for early to mid-phase studies, collaborating closely with partners across the life sciences sector to positively impact patients' lives.

The successful candidate will play a key role in ensuring the organisation’s quality standards and regulatory compliance are consistently met. This is a self-directed role requiring strong attention to detail, the ability to manage multiple priorities, and a proactive approach to quality initiatives across the business.

Reports to : Chief Operating Officer (COO)

Key Responsibilities

• Maintain and manage the Quality Management System, including Standard Operating Procedures (SOPs), Work Instructions (WIs), templates and associated forms.
• Oversee the communication, distribution, and tracking of QMS documentation.
• Ensure accurate and timely electronic filing of all QA and training-related documents (e.g., SOPs, Corrective and Preventive Action reports, training files).
• Manage oversight and tracking of CAPAs, deviations, and administrative correspondence.
• Track audit access and documentation across sponsor, vendor, and internal audits.
• Develop and maintain the annual quality plan, including quarterly updates, signature tracking, and distribution.
• Support the conduct of internal Quality Control (QC) audits for organisational studies and processes.
• Assist with the coordination and execution of external vendor due diligence and qualification audits.
• Provide training on Quality System requirements and ensure organisation-wide compliance.
• Promote awareness of the Quality Policy, Quality Manual, and related procedures across all departments.
• Work collaboratively with cross-functional teams, including Clinical Operations, Business Development, Finance, and IT.
• Keep the COO informed of progress, developments, and issues within the QA function.

Key Requirements

• Strong cultural fit; aligned with the organisation’s values and purpose.
• Self-motivated, proactive, and committed to achieving high standards.
• Ability to manage multiple tasks and priorities under time pressure.
• Excellent interpersonal and communication skills; approachable and professional.
• Comfortable in a fast-paced, collaborative team environment.
• Solid understanding of ICH-GCP, Health Canada Division 5, and FDA regulations.
• Meticulous attention to detail with strong organisational skills.
• Effective time management and a structured approach to workload and deadlines.
• Reliable and accountable; follows through on commitments.
• Team player who contributes positively to team dynamics.
• Capable of working both independently and collaboratively.
• Adaptable and flexible in response to changing priorities.
• Excellent written and verbal communication skills in English.
• Willingness to travel when required.
• Practical, confident, and solutions-focused.

To apply

• 441293778666

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Quality Assurance Specialist • Ontario, Canada, Canada