Associate Director, Clinical Quality Assurance

Role Summary

Associate Director, Clinical Quality Assurance. Location: Cambridge, US; Gaithersburg, US; New Jersey, US. Full-time.

Responsibilities

• Within the assigned clinical trials, and with the support of the supervising manager: establish and implement a proactive, risk-based Quality Strategy for trials assigned; collaborate with key internal stakeholders to ensure that clinical trial risks are detected and remediated; ensure deviations/quality issues identified are adequately investigated, including root cause analysis and implementation of robust CAPAs and Effectiveness Checks.
• Be an active member of the Clinical Trial Teams (and Core Teams, as required), including participating in meetings, reviewing clinical trial documentation, and providing guidance on day-to-day questions arising from clinical trial deliverables.
• Maintain a state of inspection readiness/quality dashboard outlining key quality aspects (issues, risks, audit findings, CAPAs, etc.) in relation to milestones.
• Interact with external partners (e.g., CROs) to ensure adequate quality oversight of clinical activities as required.
• Set up and manage strategic, proactive risk-based quality oversight on the clinical trial process to ensure continuous inspection readiness and compliance with Regulatory Authorities, GCP, internal standards, and patient safety, rights, and wellbeing.
• Support GDO functions and other QA groups for GCP Health Authority inspections preparation, facilitation, and follow-up activities.
• Oversee ongoing inspection readiness activities, develop inspection narratives, identify sites of interest for inspection (including pre-inspection visits), ensure key documents/records availability, and coordinate mock inspections with applicable teams.
• May lead back-room support for Sponsor-monitor inspections and provide remote support for investigational site inspections as applicable.
• Collaborate on the creation and implementation of Quality Agreements with CROs and clinical vendors; ensure compliance with Quality Agreement requirements and vendor compliance management for BioNTech external partners supporting GCP activities.
• Support implementation and oversight of appropriate Quality metrics and present findings to relevant stakeholders.
• Contribute to a culture of quality within BioNTech Global Development Organization and help execute the company/department strategy; follow proactive, risk-based quality approaches; leverage Quality by Design principles; provide QA and GCP expertise to achieve objectives.
• Mentor Clinical QA Compliance team members, upholding transparency, speak-up culture, and proactivity.
• Support continuous improvement initiatives and workstreams within BioNTech, addressing weaknesses and ensuring sustainable remediation.
• Authors (as delegated) or supports authoring and review of procedural documents covering clinical quality aspects.

Qualifications

Education

• University degree in life sciences

Experience

• Minimum of 5-8 years of experience in a Good Clinical Practice (GCP)-regulated environment
• Minimum of 3-5 years in a Quality Assurance (QA) position
• Inspection management experience preferred