Director/Sr. Director, Clinical Quality

Praxis Precision Medicines, Inc.; United States; On-site; USD 120,000 - 180,000; Full time

Job summary

An established industry player is seeking a Director of Clinical Quality Assurance to lead the charge in ensuring compliance with Good Clinical Practice (GCP) regulations. This pivotal role involves shaping the future of clinical trials through the development of standardized quality systems and overseeing Quality Assurance (QA) activities. The successful candidate will engage with internal teams and external partners to drive optimal quality performance and establish a culture of excellence. If you are a strategic thinker with extensive experience in clinical research quality management, this is your chance to make a significant impact on patient health and well-being globally.

Qualifications

• 10+ years in GCP or Clinical Quality Assurance roles.
• Strong knowledge of clinical trial methodology and regulatory requirements.

Responsibilities

• Lead development and maintenance of Clinical Quality Management System procedures.
• Manage inspection readiness activities and support audits by external sources.
• Collaborate with clinical study teams on quality event management.

Skills

GCP Guidelines

Clinical Quality Assurance

Regulatory Compliance

Project Management

Communication Skills

Education

Bachelor's degree in a scientific discipline

Job description

Join to apply for the Director/Sr. Director, Clinical Quality role at Praxis Precision Medicines, Inc.

Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The Opportunity

Join Praxis as the Director of Clinical Quality Assurance and take the helm in creating a culture of excellence and accountability! Reporting directly to the Vice President of Quality, this pivotal position is a unique opportunity to shape the future of clinical trials, ensuring unwavering compliance with Good Clinical Practice (GCP) regulations and standards. We are looking for a strategic thinker and hands-on leader who possesses extensive experience in quality management within clinical research. You’ll spearhead the development and implementation of consistent, standardized quality systems, working collaboratively with cross-functional clinical trial teams to embed a quality-by-design infrastructure across all studies.

You will play a critical role in overseeing and enhancing Quality Assurance (QA) activities and ensuring inspection readiness for Praxis-sponsored clinical trials, from first-in-human studies to commercial marketing authorization. Your expertise will be invaluable as you engage with both internal teams and external partners—including vendors, consultants, and service providers—to drive optimal quality performance and foster meaningful relationships. If you’re dedicated, visionary, and ready to make a significant impact in the clinical landscape, we want you to help us set the gold standard for clinical quality management at Praxis! Your contributions will directly influence our commitment to executing high-quality clinical trials, ultimately advancing the health and well-being of patients around the globe.

Primary Responsibilities

• Lead the development, management and maintenance of Clinical aspects of Praxis’ Quality Management System procedures and related processes for continuous improvement
• Lead inspection readiness activities and provide support for audits and inspections conducted by external sources (e.g., health authorities). Assist with inspection preparedness of investigator sites, GCP and GCLP vendors for BIMO inspections and inspections by other regulatory agencies.
• Manage direct reports and consultants, as needed, in pursuit of Clinical Quality Assurance objectives
• Partner with clinical study teams to coordinate appropriate and timely documentation of quality event management, including CAPA plans, as necessary
• Provide Clinical Quality Assurance (GCP) leadership and SME to clinical study teams
• Author and maintain QA SOPs. Support management of other functional area SOPs
• Support training oversight in collaboration with functional area leads
• Lead process improvement projects as needed
• Review clinical protocols, amendments, Clinical Study Reports, and other trial-related documents with QA expertise
• Plan, conduct, and/or assist in internal and external audits of service providers and clinical sites. Review audit reports and follow-up on corrective actions
• Establish and oversee vendor oversight plans and processes
• Collaborate with Clinical Operations to establish performance and quality metrics, report on these metrics, and drive improvements
• Lead investigations of critical compliance issues and escalate as appropriate to regulators and internal stakeholders

Qualifications and Key Success Factors

• Bachelor's degree in a scientific discipline or equivalent experience
• Minimum of 10 years of experience in GCP or Clinical Quality Assurance roles
• Strong knowledge of GCP guidelines, clinical trial methodology, and regulatory requirements
• Experience with FDA or other regulatory inspections
• Excellent communication skills in English
• Ability to build relationships, work collaboratively, and demonstrate integrity and innovation
• Willingness to travel approximately 25%, domestically and internationally
• Work is performed remotely; must be able to meet physical and visual requirements for a remote role