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GENERAL SUMMARYThe Senior Director of Clinical Quality Assurance (CQA) will provide strategic and operational Quality Assurance leadership and oversight for multiple, registrational, global 4DMT-sponsored clinical trials, ensuring trials are executed in compliance with applicable international regulatory requirements for Good Clinical Practice (GCP).
This position reports to the Executive Director, Quality Assurance and is accountable for advancing the CQA mission, objectives, and strategic plan through proactive quality strategy, risk-based oversight, inspection readiness, and continuous improvement of clinical quality systems.
MAJOR DUTIES & RESPONSIBILITIES:Provide strategic Quality leadership and oversight for multiple 4DMT Clinical Studies, including the followingstudy-specific activities:- Serve as a senior Quality partner to clinical study teams and leadership, providing guidance on GCP, ICH E6, and related regulations and guidance,, decision support, and escalation recommendations, including via attendance at Study team meetings, quality governance forums, and escalation discussions related to Clinical Study Quality Events.
- Lead the development, implementation, and governance of Clinical Study Quality Plans for specific 4DMT clinical studies, with accountability for protecting subject safety/rights, data integrity, and GCP compliance across assigned studies and associated vendors.
- Manage, mentor, and develop Clinical QA staff and consultants; establish clear goals, development plans, and succession depth.
- Define, plan, perform, and/or oversee risk-based GCP Compliance audits of high-risk clinical vendors/sites, including clinical investigator sites
- Ensure audit findings, quality risks, and CAPA commitments are communicated to senior stakeholders and collaborate with auditees and vendors to track, review, approve, assess the adequacy of CAPAs, and ensure timely escalation of unresolved or recurring issues
- Provide senior Quality review and strategic input on Clinical documents, ensuring quality, accuracy, completeness, and inspection readiness of key clinical and regulatory documents, including as applicable Clinical Protocols, IBs, DSURs, Module 2.6 and 2.7 Tabulated and Written Summaries, and Integrated Summaries.
Lead and/or provide oversight for investigation and management of significant Clinical Study Quality Events:- Identify, communicate, and escalate significant incidents of GCP non-compliance, quality risks, and inspection-readiness concerns, and drive timely resolution, ensuring appropriate executive visibility, escalation, and risk-based decision-making.
- Provide QA oversight for formal corrective and preventive actions (CAPAs), ensuring actions are risk-based, effective, timely, and appropriately escalated to address identified Clinical Study Quality Events, including potential serious breaches of GCP.
- Partner with CMC Quality, Clinical Operations, and senior cross-functional stakeholders to facilitate the investigation, escalation, and resolution of clinical supply quality issues such as temperature excursions, product complaints, and deviations reported from clinical sites, ensuring appropriate risk assessment, stakeholder communication, and CAPA linkage when applicable.
Champion and advance a culture of quality that fosters learning, respect, open communication, collaboration, integration, and teamwork:- Oversee and provide strategic direction for development of GCP compliance training materials and delivery of training to strengthen clinical quality culture and inspection readiness.
- Partner with Clinical Operations, Clinical Development, Biometrics, Data Management, Medical Affairs, and Regulatory Affairs to embed proactive quality and risk management into study design and conduct.
- Lead the development and continuous improvement of the Clinical Quality Management system through the development / refinement of Clinical QA processes
Lead preparedness / readiness / management of BIMO / GCP inspections:- Define and lead GCP inspection readiness strategy, plans, and cross-functional readiness activities, including readiness governance, mock inspection support, inspection logistics, and issue escalation
- Host, lead, and/or provide senior Quality support for GCP-related inspections
QUALIFICATIONS:Education: - Bachelor's degree in a life science, nursing, pharmacy, or related field; advanced degree (MS, PharmD, PhD) preferred.
Experience:- 12+ years of experience or advanced degree with 10+ years of experience within a regulated environment such as Regulatory, Quality, Pharmacovigilance or Clinical Development / Operations within the Biotech or similar
Industry
- Proven experience leading Clinical quality strategy, quality governance, and senior-level quality oversight of global clinical trials and associated vendors
- Minimum of 7 years of significant experience in clinical quality assurance, including experience leading, performing, and/or providing senior oversight of GCP audits and global clinical trials.
- Experience hosting, leading, and supporting health authority inspections, including inspection readiness preparation, front-room/back-room support, response coordination, and follow-up commitment management
- Extensive practical experience and understanding of clinical quality assurance applied throughout the clinical development life-cycle
- Demonstrated ability to influence senior cross-functional stakeholders, lead complex clinical quality initiatives, and provide mentorship or functional leadership within Clinical QA
Other Qualifications/Skills:- Expert understanding of GCP requirements for investigational products and the ability to interpret and apply requirements strategically across clinical programs
- Executive-level communication skills, both oral and written, with ability to present quality risks, recommendations, and inspection-readiness status to senior stakeholders
- Strong leadership, influencing, and interpersonal skills, with a collaborative approach to driving alignment across Clinical, Quality, Regulatory, and external vendor stakeholders
- Demonstrated ability to operate independently in a fast-paced small company environment, prioritize complex workstreams, make risk-based decisions with minimal direction, and adjust quickly to changing business 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:
$245,000 - 286,000Please 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.
