Associate Director, Clinical Quality Assurance

Associate Director, Clinical Quality Assurance

Cambridge, US;
Gaithersburg, US;
New Jersey, US | full time | Job

• Within the assigned clinical trials, and with the support of the supervising manager, 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.
• Deviations / quality issues identified are adequately investigated, including identification of root causes and implementation of robust Corrective and Preventive Actions (CAPAs) and Effectiveness Checks.
• Actively participates in Clinical Trial Teams (and Core Teams, as required), reviewing clinical trial relevant documentation and providing guidance on day‑to‑day questions arising from deliverables.
• Maintains a state of inspection readiness/quality dashboard outlining key quality aspects (issues, risks, audit findings, CAPAs, etc.) in relation to key milestones.
• Interacts with external partners, including CROs, to ensure adequate quality oversight of clinical activities.
• Participates in the set‑up and management of strategic and proactive, risk‑based quality oversight to ensure continuous inspection readiness and compliance with regulatory authorities, GCP, internal standards, and patient safety, rights and wellbeing.
• Supports GDO functions and other QA groups in GCP Health Authorities inspection preparation, facilitation, and follow‑up activities.
• Oversees ongoing inspection readiness activities, develops inspection narratives, identifies and prepares sites of interest for inspection, ensures key documents are available, and coordinates mock inspections.
• May lead back‑room support for sponsor‑monitor inspections and provide remote support for investigational site inspections.
• Collaborates on the creation and implementation of Quality Agreements with CROs and clinical vendors, ensuring compliance with executed Agreement requirements.
• Supports implementation and oversight of appropriate and relevant Quality metrics and presents during relevant meetings.
• Contributes to a culture of quality within BioNTech Global Development Organization, supporting overall strategy and vision.
• Collaborates with key stakeholders to execute company & department strategy, follow proactive and risk‑based quality approaches, leverage Quality by Design principles, and provide QA & GCP expertise.
• Mentors Clinical QA Compliance team members, upholding principles of transparency, speak‑up, and proactivity.
• Supports or contributes to continuous improvement initiatives, ensuring weaknesses are addressed and executed for sustainability.
• Authors (as delegated) or supports the authoring and review of procedural documents covering clinical quality aspects.

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.

Expected Pay Range: $163,000/year to $200,000/year + benefits, annual bonus & equity. Compensation for the role will depend on responsibilities, education, experience, knowledge, skills, and abilities.

• 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
• Sitter stream:
  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

Home to dozens of research institutions, biopharmaceutical companies, life science incubators, venture capital firms, and over 30 million square feet of laboratory space, Cambridge, Massachusetts has earned a reputation as the #1 life science cluster in the world. As part of the Greater…