Associate Director Clinical QA Compliance

Position Summary

Supports and oversees the proactive and risk-based quality strategy implementation in the drug research and development activities

Your main responsibilities are:

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:

• at the organisational level:

• contributes to a culture of quality in BioNTech GDO China 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 GDQA CN goals and company objectives

• puts efforts to work with other GDQA CN team members, while continuously upholding the principles of transparency, speak up, and proactivity

• as required, participate in the quality projects according to quality plan under GDQA CN LT oversight for the continuous improvement initiatives (including workstreams) within GDO China and ensures that areas identified as weaknesses are properly addressed and executed for sustainability

• play as the SME for the assigned or delegated area or process to support authoring and review of procedural documents covering clinical quality aspects

• complete assigned tasks, such as team administrative management, quality culture related management activities, and GDQA CN back-up program as appropriate

• at the operational/functional level (within the assigned clinical trials, and with the support of the line 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 stan