Associate Director, Clinical Quality Assurance Compliance

中国，上海   |   全职   |   Job ID: 11584 

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:
o    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
o    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
o    puts efforts to work with other GDQA CN team members, while continuously upholding the principles of transparency, speak up, and proactivity
o    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
o    play as the SME for the assigned or delegated area or process to support authoring and review of procedural documents covering clinical quality aspects
o    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):   
o    ensures that a proactive, risk-based Quality Strategy is established and implemented for trials assigned
o    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
o    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
o    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.
o    as required, interacts with external partners, including CROs, to ensure adequate quality oversight of clinical activities 
o    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.
o    Supports the GDO functions as well as other QA groups, as necessary, for GCP Health Authorities inspections preparation / facilitation / follow-up activities, including CAPAs.
o    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.
o    may lead back-room support for Sponsor-monitor inspections or provide remotes support as applicable for Health Authority investigational site inspections
o    supports organizing both internal and external quality audits, as relevant, and ensuring adequacy and completion of CAPAs and Effectiveness Checks as per their pre-defined timelines.
o    collaborates with VCM colleague on the creation and implementation of Quality Agreements with CROs and clinical vendors, as required and ensures that the executed Quality Agreement requirements are complied with along with vendor compliance management team, by BioNTech external partners supporting GCP activities
o    Supports implementation and oversight of appropriate and relevant Quality metrics and presents in study team meetings or other project meetings to applicable stakeholders

What you have to offer:

Educational Qualifications:

• Bachelor’s degree in Medicine or other Life Science. 
• Advanced degree is preferred

Professional Experience:

• Minimum 5~8 years experiences in a Good Clinical Practice (GCP) related environment
• Minimum 3~5 years Drug Development Quality Assurance or GCP related quality management roles, regulatory inspection management, QMS and Training management experience preferred
• People management experience preferred 

Additional Skills or Knowledge:

• Key understanding of drug research and development relevant regulations worldwide, including NMPA, FDA, EMA, and ICH
• Ability to work collaboratively as part of a clinical trial team and in a cross-functional, global, matrix organization
• Experience in managing escalations and CAPA support/advisement
• Ability to effectively collaborate with external stakeholders
• Computer literacy, including MS Office
• Knowledge in the use of electronic quality management systems and ability to function independently within an environment that relies heavily on technology and computer systems
• Fluent in English (written and spoken)