Supports and oversees the proactive and risk-based Quality Strategy implementation in the clinical development activities
Ensures that a proactive, risk-based Quality Strategy is established and implemented for trials assigned
Collaborates with key internal stakeholders to ensure that clinical trial risks are detected and remediated
Maintains a state of inspection readiness/quality dashboard that outlines key quality aspects
Supports the GDO functions as well as other QA groups, as necessary, for GCP Health Authorities inspections preparation / facilitation / follow-up activities
Oversees ongoing inspection readiness activities to develop inspection narratives
Collaborates on the creation and implementation of Quality Agreements with CROs and clinical vendors
Contributes to a culture of quality in BioNTech Global Development Organization

Requirements

Minimum of 5-8 (five to eight) years of experience in a Good Clinical Practice (GCP)-regulated environment
Minimum of 3-5 (three to five) years in a Quality Assurance (QA) position
Inspection management experience preferred
University degree in life sciences

Benefits

Medical, Dental and Vision Insurance
Life, AD&D, Critical Illness Insurance
Pre-tax HSA & FSA, DCRA Spending Accounts
Employee Assistance & Concierge Program (EAP) available 24/7
Parental and Childbirth Leave & Family Planning Assistance
Sitterstream: Virtual Tutoring & Childcare Membership
Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown
401(K) Plan with Company Match
Tuition Reimbursement & Student Loan Assistance Programs
Wellbeing Incentive Platforms & Incentives
Professional Development Programs
Commuting Allowance and subsidized parking
Discounted Home, Auto & Pet Insurance
…and more!

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Quality Strategy implementationinspection managementQuality Agreementsclinical trial risk managementinspection readiness activitiesGCP compliancequality dashboard maintenanceclinical development activitiesnarrative development

Soft Skills

collaborationstakeholder engagementproactive problem-solvingorganizational skillscommunication