BioNTech SE
Associate Director, Clinical Quality Assurance
BioNTech SE, Cambridge, Massachusetts, us, 02140
Associate Director, Clinical Quality Assurance
Cambridge, US; Gaithersburg, US; New Jersey, US | full time | Job ID: 9893
Responsibilities
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.
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.
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.
Your 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
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 Boston area, the city is often referred to as the “biotech supercluster” due to its high concentration of life sciences firms. This unique ecosystem is the result of a model partnership between academia and industry, fostering collaboration and innovation and driving the development of new therapies, medical devices, and diagnostics. As Cambridge’s thriving life sciences industry continues to evolve, the city remains a beacon of knowledge, innovation, and collaboration, poised to shape the future of science and technology.
Application Apply for our Cambridge, US; Gaithersburg, US; New Jersey, US location by sending your documents through our online form. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech‑Recruiter.
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Responsibilities
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.
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.
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.
Your 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
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 Boston area, the city is often referred to as the “biotech supercluster” due to its high concentration of life sciences firms. This unique ecosystem is the result of a model partnership between academia and industry, fostering collaboration and innovation and driving the development of new therapies, medical devices, and diagnostics. As Cambridge’s thriving life sciences industry continues to evolve, the city remains a beacon of knowledge, innovation, and collaboration, poised to shape the future of science and technology.
Application Apply for our Cambridge, US; Gaithersburg, US; New Jersey, US location by sending your documents through our online form. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech‑Recruiter.
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