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BioNTech SE · 1 day ago

Associate Director, Clinical Quality Assurance

Cambridge, MA

Full-time

Onsite

Lead/Staff, Director/Executive

$163K/yr - $200K/yr

5+ years exp

BioNTech SE is a pioneering biopharmaceutical company focused on advancing innovative therapies. The Associate Director Clinical QA Compliance plays a critical role in ensuring the quality and integrity of clinical development activities, implementing a proactive quality strategy, and collaborating with stakeholders to manage risks and quality issues.

Health Care

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:

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 and

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

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

Qualification

Clinical Practice (GCP)Quality Assurance (QA)Inspection managementRisk-based quality strategyClinical trial oversightContinuous improvementMentorshipCollaboration