Director* of Global Development Quality Assurance China

 

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Director* of Global Development Quality Assurance China 

 

In this role you will establish the China QA Partner team in China to support key BNT China and global business stakeholders needs. You will also establish BNT QA presence in the country for local regulatory guidance, compliance, and quality oversight and be a local resource needed to support audits and inspections, as well as local collaboration partnerships. You will define and establish China QA support model (suggested roles would be hybrid of compliance and auditing skill set).

 

Your main responsabilities:

  • Ensure compliance with unique local regulations and BNT processes in the Country
  • Align with BNT QMS and other global GDQA functions
  • Ensure proper assessment of local vendors
  • Establish QA to QA relationships with local service providers (CROs, Labs) and BNT Collaboration Partners
  • Provide Inspection support (training, preparation, and management)
  • Provide local GCP compliance, guidance, and advice
  • Serve as a member of the GDQA LT and any local QA governance initiatives, as well as local LT
  • Provide local Clinical QA Compliance, audit, and inspection support to the country, leveraging other global GDQA systems (e.g., QMS) and tools (Inspection Readiness Toolkit), and processes
  • Seek input from global GDQA team for cross-partner collaborations and align expectations for a local as well as global enabling model
  • Leads and/or supports the Global development Operational functions as well as other QA groups, as necessary, for GCP Health Authorities inspection preparation/facilitation/follow-up activities, including CAPAs
  • Supports organizing both internal and external quality audits, as relevant, and ensures adequacy of the CAPAs
  • Reviews and/or implements Quality Agreements with CROs and clinical vendors and that the Quality Agreements are compiled to support GCP activities  
  • Provides appropriate and relevant quality metrics to applicable stakeholders and can perform trending of observations and the creation of key performance indicators across auditing activities 
  • Supports the creation and updates of the risk-based audit strategy and the derived audit plan for the functions and activities under the oversight of the Global Development QA (including GCP, GCLP and Pharmacovigilance)
  • Coordinates and oversees the audits performed by external vendors, including acting as the interface with BioNTech internal functions involved with these audits
  • Oversees the adequate follow-up of issues identified during audits
  • Performs audits, including, but not limited to the following steps: preparation and review of relevant documents, audit notification to the auditees, performance of the audit including the interview of relevant personnel based on their role, verbal closeout with the auditees and relevant BioNTech personnel as applicable, authoring of the audit report and distribution of the report, follow up of the audit observations (including the review and approval of the CAPA plan)
  • Drives risk-based approach using modern and novel approaches and thinking to solving complex business problems
  • Provides expert input to functional teams in at least of the following areas: Biostats, Data management, Clinical Trial Supply and Logistics, IRT, Pre-clinical, CMC, Clinical Pharmacology, Translational Sciences, Medical Affairs, Commercial, Regulatory Affairs, Companion Diagnostics, etc.
  • Drives change initiatives in area of expertise in partnership with functional groups, setting direction and embedding quality in the design of processes and operating models with a cross-functional approach
  • Contributes to organizational quality and compliance reporting requirements
  • Prepares and delivers clear, informative and timely reports for service management
  • Establishes and maintains regular structured interactions with key stakeholders to ensure quality management and governance frameworks are created, implemented and anchored
  • Leads and collaborates with management and operational teams to adjust processes, practices as needed to meet business needs
  • Successfully collaborates with teams to identify areas for improvement and implement quality assurance measures
  • Provides strategic leadership to the team for development of programs and strategies
  • Be a role model for stakeholder advocacy, representing their quality requirements and interests

  

What you have to offer:

  • Advanced degree academic degree in Life Sciences
  • Significant experience in Good Clinical Practice (GCP) related environment, typically gained through a minimum of 15 years
  • Minimally ten years of inspection management experience and/or experience in leading an audit functional team
  • Relevant experience in building and maintaining business partner relations that include partnering with and providing service to business functions, typically gained through a minimum of 10 years
  • Robust experience in interpreting GCP guidelines for the pharmaceutical industry
  • Strong and proven team leadership experience, gained through at least 8 years of experience
  • Relevant operational experience in at least one of the following areas of expertise: Biostats, Data Management, Clinical Trial management, IRT, Pre-clinical, CMC, Clinical Pharmacology, Translational Sciences, Medical Affairs, Commercial, Regulatory Affairs, Companion Diagnostics, etc.
  • Deep knowledge and experience in drug development, development of medical devices, clinical development, research operations, GCP, GLP, GPVP, GCP for Labs, general understanding of GMP
  • Deep knowledge of process development expertise, industry standard problem-solving approaches, in alignment with Lean and Lean Six Sigma principles
  • Strong knowledge and experience in Inspection Readiness, Inspection Preparation, and Inspection Management
  • Robust experience in worldwide regulations and guidelines (including ICH, FDA, EMA, CHGRAO) related to clinical trial development and post-approval medicinal products, typically gained through a minimum of 15 years
  • Experience applying quality audit methodology, typically gained through a minimum of 15 years
  • Proven leadership with teams, mentoring, and guiding team members development
  • Strong experience in developing and maintaining a proactive, risk-based Clinical Quality Strategy
  • Experience in collaborating with key internal stakeholders and service providers (e.g. CROs) to ensure implementation of a process where 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 (ECs)
  • Experience in development and maintaining interactions with external partners, including CROs, to ensure adequate quality oversight of clinical activities
  • Developed and managed a strategic and proactive risk-based quality oversight of the clinical trial process to ensure continuous inspection readiness and compliance with Regulatory Authorities requirements, GCPs, internal standards and adherence to patients' safety, rights and wellbeing
  • Fluent in English and Mandarin, both written and oral


 

Benefits for you:

 

  • Flexible Working Time
  • Mobile Office
  • Company Pension Scheme
  • Childcare
  • Jobticket
  • Company Bike
  • Leave Account
  • Fitness Courses
     

... and much more.
 

 

Have we kindled your pioneering spirit? 

 

Then apply now for our location Shanghai and simply send us your application documents using our online form.

If you have any further questions, our Talent Acquisition Team will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon to 4 pm).

Job-ID 7258 (please indicate for inquiries)

We look forward to your application!

*BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!

BioNTech - As unique as you

www.biontech.com