Director, Clinical Quality Assurance (CQA)

GENERAL SUMMARY

The Director of Clinical Quality Assurance (CQA) will be responsible for Quality Assurance oversight of multiple, global, 4DMT sponsored clinical trials, ensuring trials are executed in compliance with all applicable international regulatory requirements for Good Clinical Practice (GCP). This position reports to the Senior Director, GCP Compliance and Quality Systems and contributes to the development, implementation, and successful execution of the CQA mission, objectives, and strategic plan.

MAJOR DUTIES & RESPONSIBILITIES:

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

Support investigation and management of specific Clinical Study Quality Events as assigned:

• Monitor, track, and facilitate the completion of formal corrective and preventive actions (CAPAs) to address identified Clinical Study Quality Events, including potential serious breaches of GCP.

Support a quality-focused work environment in Clinical that fosters learning, respect, open communication, collaboration, integration, and teamwork:

• Work with Clinical stakeholders to develop GCP compliance training materials and conduct training
• Partner with Clinical team to review, update and maintain related SOPs, identify the need for new SOPs, and support the review of new SOPs as needed
• Work with Clinical stakeholders to support Training, Development, and Implementation of 4DMT Clinical Study Risk Management Process/Tools to ensure principles of Risk Management are applied to 4DMT Clinical Studies per ICH E6
• Drive the development and continuous improvement of the Clinical Quality Management System through the development / refinement of Clinical QA processes

Support preparedness / readiness / management of BIMO inspections:

• Develop/support GCP inspectional readiness plans and lead inspectional readiness activities
• Host and/or assist with management of GCP-related inspections
• Partner with GMP Quality and Clinical Operations teams to facilitate the investigation of clinical supply quality issues such as temperature excursions, product complaints and deviations reported from clinical sites.

QUALIFICATIONS:

Education:

• S./B.A. degree in a science or related life science field or equivalent; advanced scientific degree preferred.

Experience:

• 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

Other Qualifications/Skills:

• 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

Travel: %5

Physical Requirements and Working Conditions:

• Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.
• Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met.
• Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

Base salary compensation range: $205,000 - $235,000

Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.