Director, Clinical Quality Assurance

Reports to: Senior Vice President, Technical Operations

Location: Remote or Plymouth Meeting, PA (Hybrid)

Company Overview:

Braeburn is dedicated to delivering solutions for people living with the serious consequences of opioid use disorder. At Braeburn, we challenge the status quo and champion transformation of the management of opioid use disorder (OUD) by partnering with the community to create a world where every person with OUD gets the best possible care and opportunity to reach their full potential. Our shared commitment to innovation on behalf of patients enables us to help people with OUD begin and sustain recovery.

At Braeburn, there are opportunities to contribute to our purpose every day. We value authenticity and strive to amplify all voices. Our culture empowers everyone to be successful and unleashes our full potential.

Position Summary:

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. This role provides oversight of all third-party vendors involved in clinical development, including CROs, laboratories, and suppliers, ensuring adherence to Good Clinical Practice (GCP) and inspection readiness for regulatory agencies.

This role partners closely with Clinical Operations and Medical Affairs leadership to ensure clinical trial execution, oversight, and medical activities are conducted in compliance with GCP, regulatory expectations, and internal quality standards.

Specific Duties:

Quality Management System

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).

Quality Oversight of CROs and Vendors

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.

Risk and Compliance

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.

Training and Communication

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.

Skills:

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.

Education/Experience:

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

Braeburn is committed to ensuring equal employment opportunity for all qualified applicants regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, military/veteran status, age, disability, or any other category/characteristic protected by law (collectively, "Protected Categories"). In fact, we encourage all underrepresented backgrounds to apply for any open job positions with the company.

Braeburn Job Scam Warning

At Braeburn, we prioritize the security of your personal information. Be aware of individuals falsely presenting themselves as Braeburn employees or representatives to gain access to your personal information or money through fictitious job offers.

Braeburn will never ask…