Associate Director, Clinical Quality Assurance

BioNTech • Cambridge, MA

121d • $146,300 - $234,100

About The Position

The Associate Director, Clinical Quality Assurance Compliance helps ensure clinical trials meet Good Clinical Practice (GCP) requirements and protect patient safety, rights, and wellbeing. The role provides proactive, risk-based quality oversight in support of BioNTech’s clinical development.

The position partners with clinical trial teams, internal quality groups, and external vendors. Its scope includes trial oversight, inspection readiness, audits, and continuous improvement, helping teams identify and address quality risks throughout clinical development.

Requirements

• University degree in life sciences.
• 5–8 years of experience in a Good Clinical Practice-regulated environment, including 3–5 years in a Quality Assurance role.
• Knowledge of clinical trial quality oversight, risk management, investigations, corrective and preventive actions, and inspection readiness.
• Proactive, collaborative approach with sound judgment and a commitment to transparency and continuous improvement.

Nice To Haves

• Experience managing or supporting health authority inspections.

Responsibilities

• Set and oversee risk-based quality strategies for assigned clinical trials to support compliance and patient protection.
• Advise trial teams on quality risks, deviations, investigations, root causes, corrective and preventive actions, and effectiveness checks.
• Maintain trial quality dashboards and coordinate inspection-readiness activities, including preparation of sites, records, narratives, and mock inspections.
• Support health authority inspections, audits, and follow-up activities, including back-room support and timely completion of corrective actions.
• Oversee quality aspects of clinical vendors, including quality agreements, partner compliance, and relevant quality metrics.
• Strengthen the organization’s quality culture by mentoring colleagues, improving processes, and contributing to clinical quality procedures.

Benefits

• Competitive remuneration package.
• Benefits supporting employee wellbeing and a diverse employee base.
• Annual bonus and equity for US positions; bonus and equity are variable and dependent on company and individual performance.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior