Associate Director, Clinical Quality Assurance
BioNTech SE
6 hours ago
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Your contribution:
- Ensures a proactive, risk-based Quality Strategy is established and implemented for assigned clinical trials.
- Collaborates with internal stakeholders to ensure clinical trial risks are detected and remediated.
- Ensures deviations/quality issues are investigated (root cause analysis) and that robust Corrective and Preventive Actions (CAPAs) and Effectiveness Checks are implemented.
- Participates in Clinical Trial Teams (and Core Teams, as required): attends meetings, reviews clinical trial documentation, and provides guidance on day-to-day questions related to trial deliverables.
- Maintains an inspection readiness/quality dashboard covering key issues, risks, audit findings, CAPAs, and key milestones.
- Interacts with external partners (e.g., CROs) to ensure adequate quality oversight of clinical activities.
- Sets up and manages proactive, risk-based quality oversight to ensure continuous inspection readiness and compliance with Regulatory Authorities requirements, GCP, internal standards, and patient safety/rights/wellbeing.
- Supports GDO/QA groups for Health Authority inspection preparation, facilitation, and follow-up.
- Develops inspection narratives; identifies/prepares sites of interest for inspection (including pre-inspection support); ensures availability of key documents/records; coordinates mock inspections.
- May lead back-room support for Sponsor-monitor inspections and provide remote support for investigational site inspections.
- Collaborates on creation/implementation of Quality Agreements with CROs and clinical vendors; ensures executed Quality Agreement requirements and vendor compliance management expectations are met.
- Supports implementation/oversight of quality metrics and presents to stakeholders.
- Contributes to a culture of quality and executes the Quality Organization strategy/vision.
- Collaborates with stakeholders to leverage Quality by Design principles and provide QA/GCP expertise.
- Mentors Clinical QA Compliance team members; upholds transparency, “speak up,” and proactivity.
- Supports continuous improvement initiatives and ensures weakness areas are addressed sustainably.
- Authors (as delegated) and/or supports authoring and review of clinical quality procedural documents.
A good match:
Education
- University degree in life sciences
Experience
- 5–8+ years in a Good Clinical Practice (GCP)-regulated environment
- 3–5+ years in a Quality Assurance (QA) position
- Inspection management experience preferred
Benefits (as stated):
- Medical, Dental and Vision Insurance; Life/AD&D/Critical Illness Insurance
- Pre-tax HSA/FSA, DCRA Spending Accounts
- Employee Assistance & Concierge Program (EAP) 24/7
- Parental and Childbirth Leave & Family Planning Assistance
- Sitterstream: Virtual Tutoring & Childcare Membership
- Paid Time Off (Vacation, Sick, Bereavement, Holidays, Year-End U.S. Shutdown)
- 401(K) Plan with company match
- Tuition Reimbursement & Student Loan Assistance
- Wellbeing Incentive Platforms & Incentives; Professional Development Programs
- Commuting allowance and subsidized parking
- Discounted Home/Auto/Pet insurance
Application instructions:
- Apply for the Cambridge, US; Gaithersburg, US; New England, US; New Jersey, US location and submit documents using the online form.
- Ensures a proactive, risk-based Quality Strategy is established and implemented for assigned clinical trials.
- Collaborates with internal stakeholders to ensure clinical trial risks are detected and remediated.
- Ensures deviations/quality issues are investigated (root cause analysis) and that robust Corrective and Preventive Actions (CAPAs) and Effectiveness Checks are implemented.
- Participates in Clinical Trial Teams (and Core Teams, as required): attends meetings, reviews clinical trial documentation, and provides guidance on day-to-day questions related to trial deliverables.
- Maintains an inspection readiness/quality dashboard covering key issues, risks, audit findings, CAPAs, and key milestones.
- Interacts with external partners (e.g., CROs) to ensure adequate quality oversight of clinical activities.
- Sets up and manages proactive, risk-based quality oversight to ensure continuous inspection readiness and compliance with Regulatory Authorities requirements, GCP, internal standards, and patient safety/rights/wellbeing.
- Supports GDO/QA groups for Health Authority inspection preparation, facilitation, and follow-up.
- Develops inspection narratives; identifies/prepares sites of interest for inspection (including pre-inspection support); ensures availability of key documents/records; coordinates mock inspections.
- May lead back-room support for Sponsor-monitor inspections and provide remote support for investigational site inspections.
- Collaborates on creation/implementation of Quality Agreements with CROs and clinical vendors; ensures executed Quality Agreement requirements and vendor compliance management expectations are met.
- Supports implementation/oversight of quality metrics and presents to stakeholders.
- Contributes to a culture of quality and executes the Quality Organization strategy/vision.
- Collaborates with stakeholders to leverage Quality by Design principles and provide QA/GCP expertise.
- Mentors Clinical QA Compliance team members; upholds transparency, “speak up,” and proactivity.
- Supports continuous improvement initiatives and ensures weakness areas are addressed sustainably.
- Authors (as delegated) and/or supports authoring and review of clinical quality procedural documents.
A good match:
Education
- University degree in life sciences
Experience
- 5–8+ years in a Good Clinical Practice (GCP)-regulated environment
- 3–5+ years in a Quality Assurance (QA) position
- Inspection management experience preferred
Benefits (as stated):
- Medical, Dental and Vision Insurance; Life/AD&D/Critical Illness Insurance
- Pre-tax HSA/FSA, DCRA Spending Accounts
- Employee Assistance & Concierge Program (EAP) 24/7
- Parental and Childbirth Leave & Family Planning Assistance
- Sitterstream: Virtual Tutoring & Childcare Membership
- Paid Time Off (Vacation, Sick, Bereavement, Holidays, Year-End U.S. Shutdown)
- 401(K) Plan with company match
- Tuition Reimbursement & Student Loan Assistance
- Wellbeing Incentive Platforms & Incentives; Professional Development Programs
- Commuting allowance and subsidized parking
- Discounted Home/Auto/Pet insurance
Application instructions:
- Apply for the Cambridge, US; Gaithersburg, US; New England, US; New Jersey, US location and submit documents using the online form.