Director, Quality Assurance

Clarivate is seeking a dynamic Director, Quality Assurance to join our Regulatory Compliance team. In this role you will be responsible for the day-to-day implementation and ongoing oversight of a formalized Quality Management System (QMS) for a suite of GxP-regulated product and services offerings.  This role will act as the primary point of contact for all Quality/Compliance needs for the in-scope business line, and will work with the Head of Quality and other members of the Regulatory Compliance team to meet both compliance and business needs.  

This is an amazing opportunity to work on the Quality and Compliance aspects of Clarivate’s GxP offerings in the Life Sciences & Healthcare business segment. The wider Quality/Compliance team consists of 6 colleagues reporting to the V.P. of Regulatory Compliance. We have a great skill set in GxP Quality, regulatory compliance, computerized systems validation (CSV), ISO and other industry standards/best practices and we would love to speak with you if you have skills in providing quality/compliance-related guidance, governance, and oversight, formal computerized systems validation, process improvement and procedural development. 

 
About You – experience, education, skills, and accomplishments 

• Bachelor’s degree or equivalent  

• 7+ years of experience in a Quality Assurance or Regulatory Compliance role in a related industry  

It would be great if you also had… 

• 7+ years of experience in Computer Systems Validation (CSV) and tools qualification  

• 7+ years of experience in creating and maintaining SOPs  

• Experience with eQMS platforms, Jira, and Agile software development/validation methodology is preferred 

• Familiarity with regulations and industry standards to support compliance goals 

What will you be doing in this role? 

• Acting as the dedicated point of contact to manage all Quality/Compliance needs for a suite of products 

• Overseeing the overall process for, and directly producing Quality/Compliance deliverables, related to Computer Systems Validation (CSV) of software in the in-scope business line 

• Coordinating and working with the larger Regulatory Compliance team and the business to ensure the overall QMS is implemented, maintained in a compliant state, and adhered to by all in-scope colleagues, including training, audits, supplier qualification/management, CSV, etc.  

• Designing, implementing, and improving company quality/compliance standards and practices to ensure compliance with industry best practices and regulations 

• Developing and implementing process/continuous improvement programs 

• Analyzing data to find areas for growth and making recommendations to the business pertaining to same 

• Training, motivating, coaching, and correcting employees to ensure that standards are met, and acting as point of contact for colleagues within the in-scope business line 

• Creating and/or updating reports/metrics to assist in tracking progress to goals and conducting trending analyses 

• In conjunction with the business, documenting KPIs and