Senior Compliance Manager Localization in Life Sciences - US East Coast Time Zone

This is a remote position.

As a result of strong growth in life sciences localization this is a newly added role for our client a large global Language Service Provider. The responsibilities of the Senior Compliance Specialist will include supporting oversight of key controls in particular within the life sciences area identifying and evaluation of any new requirements or regulations maintaining various compliance systems to implement action plans and strive for continuous improvement.

Responsibilities

• Create develop and implement company compliance policies and procedures
  
• Manage internal and external audit processes as required
  
• Manage compliance and improvements through ongoing monitoring of effectiveness assessment and development
  
• Running of CAPA programs Conduct investigations into compliance incidents Identify RCA and Recommending corrective actions
  
• Provide compliance training to internal and external stakeholders in collaboration with the Head of Compliance and Quality
  
• Assist with management of the Quality Management System
  
• Work closely with both the Chief Operations Officer and the Head of Compliance & Quality on the development and implementation of compliance reporting tools and metrics
  
• Provide support and advice to various business units within the company
  
• Monitor ongoing regulatory changes or guidance in best practice that may impact our programs
  

Requirements

• 3 years experience within compliance audit risk or similar experience within the Life Sciences or Localisation Sector
  
• Experience working within and achieving and maintaining ISO standards; the company is currently certified to ISO 9001:2015 ISO 13485:2016 ISO 17100:2015 ISO 18587:2017 and ISO 27001:2013.
  
• Experience managing regulatory requirements including FDA regulations
  
• Preferable: experience working within the localization industry
  
• Ability to capture data analyze results and follow through on required actions
  
• Fluent in English (any other languages an asset)
  
• Ability to work independently and also collaborate with and influence stakeholders & external partners in a fastmoving global organization
  
• Ability to communicate change in a considered and productive manner
  
• Ideally experience working within a multicultural and global environment