Salary :
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This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior / Project Quality Assurance Lead based in Canada.
This role sits at the center of clinical quality oversight, ensuring that global research projects are conducted in full compliance with GCP standards, regulatory requirements, and internal quality systems. You will act as a trusted quality expert, partnering with cross-functional study teams to proactively identify risks and strengthen compliance across complex clinical programs. The position involves leading quality issue investigations, guiding root cause analysis, and ensuring robust corrective and preventive actions are implemented effectively.
You will also provide hands-on support for audits, regulatory inspections, and sponsor quality interactions.
A key part of the role involves applying a risk-based mindset to continuously improve study quality and operational performance.
This is a highly collaborative and influential position where your expertise directly supports study integrity, regulatory readiness, and patient safety across global trials.
The environment is fast-paced, scientific, and mission-driven, ideal for professionals who thrive in complex, regulated settings and enjoy shaping quality culture at scale.
Accountabilities:
- Act as GCP subject matter expert, providing guidance to project teams to ensure compliance with study protocols, ICH-GCP standards, and applicable global regulations.
- Lead quality issue management activities, including investigations, root cause analysis, deviation assessment, and CAPA development.
- Drive proactive risk management by identifying potential quality risks and implementing mitigation strategies across assigned projects.
- Perform quality assurance reviews, trend analysis, and monitoring of key quality metrics to ensure continuous compliance.
- Support and contribute to sponsor audits, regulatory inspections, and clinical investigator site audit activities.
- Collaborate with internal QA stakeholders and external sponsor counterparts to ensure alignment on quality expectations and outcomes.
- Provide expert consultation on quality management systems and support ongoing process improvement initiatives.
Requirements:
- Bachelor’s degree in life sciences, pharmacy, health sciences, or related field (Master’s degree or equivalent experience preferred).
- 5+ years of GCP experience, or 3+ years with a Master’s degree, within a CRO or pharmaceutical environment.
- Strong knowledge of ICH-GCP guidelines, FDA regulations, EU directives, UK regulatory frameworks, and broader GxP standards.
- Experience supporting or participating in regulatory inspections and clinical quality audits.
- Solid understanding of clinical drug development processes and quality management systems.
- Proven ability in root cause analysis, CAPA development, and quality issue resolution.
- Strong communication, influencing, and stakeholder management skills across global teams.
- Ability to manage multiple priorities independently in a fast-paced, deadline-driven environment.
- Willingness to travel domestically and internationally as required (up to ~15%).
Benefits:
- Competitive annual salary ranging from $65,500 to $130,500 USD, based on experience, qualifications, and internal equity.
- Comprehensive benefits package including medical, dental, vision, and additional health coverage (varies by eligibility and location).
- Fully remote flexibility within Canada and select international alignment options depending on project needs.
- Exposure to global clinical trials, sponsor audits, and high-impact regulatory interactions.
- Strong focus on professional development within a leading clinical research environment.
- Opportunity to contribute to patient-focused research programs with global reach.
- Inclusive, collaborative culture that values scientific rigor, innovation, and continuous improvement.
- Travel opportunities for audits, inspections, and cross-functional project support.
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