Associate Director, Clinical Quality Assurance

BioNTech•Cambridge, MA

53d•$163,000 - $200,000

About The Position

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 risked 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 remotes 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

Requirements

University degree in life sciences
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

Nice To Haves

Inspection management experience preferred

Responsibilities

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 risked 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 remotes 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
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

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