Associate Director, Clinical Quality Assurance

Role Summary

Associate Director Clinical QA Compliance at BioNTech. Responsible for implementing a proactive, risk-based quality strategy across assigned clinical trials to safeguard compliance with Good Clinical Practice (GCP) standards, regulatory requirements, and internal quality principles. Collaborates with internal and external stakeholders, including CROs and clinical vendors, to detect risks, remediate issues, and manage quality across clinical development activities. Requires 5-8+ years in a GCP-regulated environment and 3-5+ years in QA, with a proven track record in inspection management. Location includes Cambridge, MA; Gaithersburg, MD; and New Jersey.

Responsibilities

• Establish and implement a proactive, risk-based Quality Strategy for assigned trials with supervision as needed.
• Collaborate with internal stakeholders to ensure clinical trial risks are detected and remediated; ensure deviations/quality issues are adequately investigated with root-cause analysis and robust CAPAs and Effectiveness Checks.
• Actively participate in Clinical Trial Teams and Core Teams; review trial documentation and provide guidance on day-to-day deliverables.
• Maintain an inspection readiness/quality dashboard outlining key quality aspects (issues, risks, audit findings, CAPAs) relative to milestones.
• Interact with external partners (e.g., CROs) to ensure quality oversight of clinical activities.
• Set up and manage strategic, risk-based quality oversight to ensure ongoing inspection readiness and regulatory/GCP compliance.
• Support GDO functions and other QA groups for GCP Health Authority inspections preparation, facilitation, and follow-up.
• Oversee inspection readiness activities: develop narratives, identify sites of interest, prepare key documents, and coordinate mock inspections; provide back-room support for sponsor-monitor inspections as needed.
• Collaborate on Quality Agreements with CROs and clinical vendors; ensure executed agreements are complied with and vendor teams adhere to requirements.
• Support and oversight of quality metrics; present findings at relevant stakeholder meetings.
• Promote a culture of quality within BioNTech Global Development Organization; align with company and department strategies, quality by design, and QA/GCP guidance.
• Mentor Clinical QA Compliance team members and support continuous improvement initiatives; contribute to sustainable solutions.
• Author or support the 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