Associate Director, Clinical Quality Assurance
BioNTech IMFS, Cambridge, Massachusetts, us, 02140
Associate Director, Clinical Quality Assurance
Cambridge, US; Gaithersburg, US; New Jersey, US | full time | Job ID: 9893
Responsibilities
The Associate Director Clinical QA Compliance supports and oversees the proactive and risk‑based Quality Strategy implementation in the clinical development activities, including, but not limited to the below:
1) 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 1) clinical trial risks are detected and remediated and 2) deviations / quality issues identified are adequately investigated, including identification of root causes and implementation of robust Corrective and Preventive Actions (CAPAs) and Effectiveness Checks
Is an active member of the Clinical Trial Teams (and Core Teams, as required), including through participating in meetings, reviewing clinical trial relevant documentation and providing guidance to day‑to‑day questions arising from clinical trial deliverables
Maintains a state of inspection readiness/quality dashboard that outlines key quality aspects (e.g. issues, risks, audit findings, CAPAs, etc.) in relation to the key milestones.
As required, interacts with external partners, including CROs, to ensure adequate quality oversight of clinical activities
Participates in the set up and management of strategic and pro‑active risk‑based quality oversight on the clinical trial process to ensure continuous inspection readiness and compliance with Regulatory Authorities requirements and GCP, internal standards and adherence to patients' safety, rights and wellbeing
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, identifies and prepares sites of interest for inspection (including pre‑inspection visit support), ensures availability of key documents/records and coordinates mock inspection with applicable teams
May lead back‑room support for Sponsor‑monitor inspections. May provide remote support as applicable for investigational site inspections
Collaborates on the creation and implementation of Quality Agreements with CROs and clinical vendors, as required. Ensures that the executed Quality Agreement requirements are complied with along with vendor compliance management team, by BioNTech external partners supporting GCP activities
Supports implementation and oversight of appropriate and relevant Quality metrics and presents during relevant meetings to applicable stakeholders
2) at an organizational level:
Contributes to a culture of quality in BioNTech Global Development Organization to positively impact the business and implement the overall strategy and vision of the Quality Organization
Collaborates with key stakeholders to execute the company & department strategy, follow proactive and risk‑based quality approaches, leverage Quality by Design principles, and provides QA & GCP expertise and guidance to achieve company objectives
Mentors Clinical QA Compliance team members, while continuously upholding the principles of transparency, speak up, and proactivity
As required, supports/contributes to the continuous improvement initiatives (including workstreams) within BioNTech and ensures that areas identified as weaknesses are properly addressed and executed for sustainability
Authors (as delegated) / supports 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
Expected Pay Range
$163,000/year to $200,000/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.
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
Professional Development Programs
Commuting Allowance and subsidized parking
Discounted Home, Auto & Pet Insurance
Apply now – We look forward to your application!
Apply for our Cambridge, US; Gaithersburg, US; New Jersey, US locations and simply send us your documents using 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.
BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer.
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Responsibilities
The Associate Director Clinical QA Compliance supports and oversees the proactive and risk‑based Quality Strategy implementation in the clinical development activities, including, but not limited to the below:
1) 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 1) clinical trial risks are detected and remediated and 2) deviations / quality issues identified are adequately investigated, including identification of root causes and implementation of robust Corrective and Preventive Actions (CAPAs) and Effectiveness Checks
Is an active member of the Clinical Trial Teams (and Core Teams, as required), including through participating in meetings, reviewing clinical trial relevant documentation and providing guidance to day‑to‑day questions arising from clinical trial deliverables
Maintains a state of inspection readiness/quality dashboard that outlines key quality aspects (e.g. issues, risks, audit findings, CAPAs, etc.) in relation to the key milestones.
As required, interacts with external partners, including CROs, to ensure adequate quality oversight of clinical activities
Participates in the set up and management of strategic and pro‑active risk‑based quality oversight on the clinical trial process to ensure continuous inspection readiness and compliance with Regulatory Authorities requirements and GCP, internal standards and adherence to patients' safety, rights and wellbeing
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, identifies and prepares sites of interest for inspection (including pre‑inspection visit support), ensures availability of key documents/records and coordinates mock inspection with applicable teams
May lead back‑room support for Sponsor‑monitor inspections. May provide remote support as applicable for investigational site inspections
Collaborates on the creation and implementation of Quality Agreements with CROs and clinical vendors, as required. Ensures that the executed Quality Agreement requirements are complied with along with vendor compliance management team, by BioNTech external partners supporting GCP activities
Supports implementation and oversight of appropriate and relevant Quality metrics and presents during relevant meetings to applicable stakeholders
2) at an organizational level:
Contributes to a culture of quality in BioNTech Global Development Organization to positively impact the business and implement the overall strategy and vision of the Quality Organization
Collaborates with key stakeholders to execute the company & department strategy, follow proactive and risk‑based quality approaches, leverage Quality by Design principles, and provides QA & GCP expertise and guidance to achieve company objectives
Mentors Clinical QA Compliance team members, while continuously upholding the principles of transparency, speak up, and proactivity
As required, supports/contributes to the continuous improvement initiatives (including workstreams) within BioNTech and ensures that areas identified as weaknesses are properly addressed and executed for sustainability
Authors (as delegated) / supports 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
Expected Pay Range
$163,000/year to $200,000/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.
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
Professional Development Programs
Commuting Allowance and subsidized parking
Discounted Home, Auto & Pet Insurance
Apply now – We look forward to your application!
Apply for our Cambridge, US; Gaithersburg, US; New Jersey, US locations and simply send us your documents using 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.
BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer.
#J-18808-Ljbffr