Quality Assurance Consultant

Position Overview

In this role, you will be responsible for successfully leading quality assurance projects within the pharmaceutical and medical device sectors. Your expertise in cell therapy manufacturing, cloud-based data management systems, and medical device remediation will be crucial in ensuring regulatory compliance and quality standards are met. You will act as a mediator and communicator between technical teams and regulatory bodies, applying industry best practices to achieve optimal outcomes. Mentoring and coaching internal teams will be a key aspect of this role, as you guide them in risk-based approaches and regulatory compliance strategies.

Responsibilities

Cell Therapy Manufacturing Data Integrity Remediation Deviations:

 

• Collaborate with key stakeholders to develop a remediation plan for addressing current AIQ work identified through working with CT CSQA
• Lead the transition from unstructured requests to a structured, prioritized, risk-based remediation project
  
   

Scientific Data Management System Implementation In The Cloud

 

• Assess and initiate a quality approach for system implementation in multiple geographic areas, including validation and qualification needs
• Align CSQA with a risk-based approach for project implementation, collaborating with the vendor
  
   

Medical Device Remediation Project

 

• Implement a risk-based approach to reduce the effort required for remediation
• Guide the appropriate level of validation/qualification considering audit findings, patient safety, product quality, and technical feasibility
• Identify, track, and develop a risk-based plan to address re-occurring issues by leveraging data analysis and AI technology
  
   

Mentoring Internal Quality Engineers And POD Teams

 

• Coach and develop an internal team of Quality Engineers and IT staff in risk-based approaches, regulatory compliance, and liaison strategies
  
   

Qualifications

 

• Extensive experience in quality assurance and regulatory compliance within the pharmaceutical and medical device sectors
• Strong expertise in cell therapy manufacturing, cloud-based data management systems, and medical device remediation
• Proven ability to mediate and communicate between technical teams and regulatory bodies
• Strong networking skills with a track record of applying industry best practices
• Excellent mentorship and coaching abilities
• Knowledge of GMP, GLP, GxP, and other relevant regulatory standards
• Familiarity with Lean and Agile Software Development Lifecycle Procedure
• Fluent in German
  
   

Additional Requirements

 

• Robust network within the pharmaceutical industry to facilitate the exchange of best practices and compliance strategies
• Flexibility to work in projects executed in different time zones (USA, Europe, Japan)
• Experience with Jira
  
   

Join our team to make a meaningful impact in the pharmaceutical and medical device sectors. Apply your expertise in quality assurance and regulatory compliance to drive successful projects and mentor internal teams. Showcasing your ability to mediate between technical teams and regulatory bodies, you will play a vital role in ensuring adherence to industry standards and best practices. Flexibility in working across different time zones and fluency in German will be valuable assets in this position. Apply now to take the next step in your career!

Employment Type: Contractor