Braeburn
Director, Clinical Quality Assurance
Plymouth Meeting, PA · Director
Sponsorship not specifiedDetected 15 days ago
GCPData AnalysisClinical TrialsClinical ResearchFDA RegulatoryResearchLeadershipCommunicationCollaborationPublic SpeakingGxP
About the role
- Braeburn is dedicated to delivering solutions for people living with the serious consequences of opioid use disorder.
- 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.
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).
- Implements proactive risk identification and mitigation processes.
- 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.
Requirements
- Significant experience with QA review of Clinical Protocols, CAPA reports, SOPs, change control processes, deviation/investigation reports, computer systems validation, QA agreements, audit reports
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
- Education/Experience:
- Deep knowledge of international guidelines ICH-GCP as well as relevant local regulations
- 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 Job Scam Warning
- Braeburn will never ask for financial information or payment during the job application process.
- Braeburn is not liable for losses resulting from job recruiting scams.
- Braeburn does not accept unsolicited assistance from search firms for employment opportunities.
Company info
- Our culture empowers everyone to be successful and unleashes our full potential.
- Monitors CRO performance and ensures compliance with GCP and company standards.
Visa & Work Authorization
- Maintain inspection readiness for sponsor and regulatory inspections (FDA, EMA)
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This listing is sourced directly from Braeburn's careers page and normalized into a canonical job model.