Provide Quality oversight for multiple 4DMT Clinical Studies, including the following study-specific activities:
Develop and implement Clinical Study Quality Plans for specific 4DMT clinical studies, focused on ensuring subject safety/rights, study data integrity, and GCP compliance.
Provide guidance and support to clinical study teams, including via attendance at Study team meetings and via investigation and management of Clinical Study Quality Events.
Ensure principles of Risk Management are applied to the Clinical Study per ICH E6.
Identify, communicate, and escalate significant incidents of GCP non-compliance and follow to resolution, acting at all times with an appropriate sense of urgency.
Plan, perform, and/or oversee GCP Compliance audits of high-risk clinical vendors/sites, including clinical investigator sites.
Ensure audit findings are communicated to audit stakeholders and collaborate with auditees and vendors to track, review, approve, and assess the adequacy of CAPAs.
Perform Clinical Document reviews, ensuring the quality, accuracy and completeness of various documents, including as applicable Clinical Protocols, IBs, DSURs, Module 2.6 Tabulated and Written Summaries, and Integrated Summaries.

S./B.A. degree in a science or related life science field or equivalent; advanced scientific degree preferred.
10+ years of experience or advanced degree with 7+ years of experience within a regulated environment such as Regulatory, Quality, Pharmacovigilance or Clinical Development / Operations within the Biotech or similar Industry
Proven experience with GCP Quality Management Systems, quality support, and quality oversight of global clinical trials
Minimum of 4 years of significant experience in clinical quality assurance, including experience performing/supporting GCP audits and overseeing global clinical trials, including in APAC.
Extensive practical experience and understanding of clinical quality assurance as applied throughout the clinical development life-cycle
(Optional) 5+ years of management experience or other specific work experience.
In-depth understanding of GCP requirements for investigational products.
Excellent communication skills, both oral and written.
Excellent interpersonal skills, collaborative approach essential.
Comfortable in a fast-paced small company environment with minimal direction and able to adjust to workload based upon changing priorities.

Director, Clinical Quality Assurance – CQA

Key skills