Braeburn · 19 hours ago
Director of Clinical Quality Assurance
Plymouth Meeting, PA
Full-time
Hybrid
Director/Executive
10+ years expBraeburn is dedicated to delivering solutions for people living with the serious consequences of opioid use disorder. The Director of Clinical Quality Assurance (CQA) is responsible for developing, implementing, and maintaining the company’s Clinical Quality Management System (QMS) to ensure compliance with Good Clinical Practices (GCP) regulatory requirements and industry standards.
Health CareMedical DevicePharmaceutical
Responsibilities
Leads all Clinical Quality Assurance (QA) activities within the company
Develops, implements, and maintains all clinical quality assurance systems, processes, and procedures
Develops and tracks clinical quality metrics, approves all deviations, and develops Corrective and Preventative Actions (CAPAs)
Lead management review meetings and ensure continuous improvement
Maintain inspection readiness for sponsor and regulatory inspections (FDA, EMA)
Qualifies and audit CROs and clinical suppliers per internal SOPs
Monitors CRO performance and ensures compliance with GCP and company standards
Reviews CRO documentation (e.g., SOPs, TMF, risk management plans) for adequacy
Implements proactive risk identification and mitigation processes
Coordinates clinical site audits and ensure timely resolution of findings
Ensures compliance with ICH guidelines, FDA regulations, and Part 11 requirements
Build and roll out QA training programs for internal staff and CRO partners
Serve as the primary QA contact for clinical teams and external partners
Qualification
Required
Established GCP QA professional
Robust understanding of quality management systems and GxP to ensure compliance with regulatory requirements
Excellent critical data analysis, written, and oral communication skills
Strong experience in QA Audits of Clinical sites and Third-party organizations
Demonstrated ability to successfully interact with regulatory health authorities at inspections as well as lead all preparation, hosting, and follow-up activities
Ability to lead and influence cross functional employees to ensure compliance, and able to enhance team performance through strong collaboration skills
Robust knowledge of successful delivery of a clinical study, e.g., ICH-GCP, study management, site management, monitoring, SOPs, training, etc
BA/BS in related field with at least 10 years of Quality Assurance experience in pharmaceutical GCP operations or related quality technical role in the medical space
Deep knowledge of international guidelines ICH-GCP as well as relevant local regulations
Significant experience with QA review of Clinical Protocols, CAPA reports, SOPs, change control processes, deviation/investigation reports, computer systems validation, QA agreements, audit reports
Experience utilizing QMS metrics, KPIs, and QTLs to assess risks to clinical research and drug development processes
Demonstrated expertise in leading organizational and planning activities
Company
Braeburn
We transform the management of OUD to help people begin and sustain recovery.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$133MKey Investors
Wellington Capital Management
2018-01-10Debt Financing· $110M
2016-01-01Series Unknown· $23M
Leadership Team
Mike Derkacz
President, CEO and Board Director
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