Senior Compliance Manager Localization in Life Sciences - US EST or BSTCET Time Zone

This is a remote position.

As a result of strong growth in life sciences localization we have 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 evaluating any new requirements or regulations maintaining various compliance systems to implement action plans and striving for continuous improvement.

Responsibilities

The Senior Compliance Specialist will contribute to the development enhancement and maintenance of compliance programs working closely with the Chief Operations Officer the Head of Compliance & Quality and other key internal stakeholders.

Responsibilities:

• Creating developing and implementing company compliance policies and procedures.
  

• Managing internal and external audit processes as required.
  

• Managing compliance and improvements through ongoing monitoring of effectiveness assessment and development.
  

• Running CAPA programs conducting investigations into compliance incidents identifying RCA and recommending corrective actions.
  

• Providing compliance training to internal and external stakeholders in collaboration with the Head of Compliance and Quality.
  

• Assisting with the management of the Quality Management System.
  

• Working closely with both the Chief Operations Officer and the Head of Compliance & Quality on the development and implementation of compliance reporting tools and metrics.
  

• Providing support and advice to various business units within the company.
  

• Monitoring ongoing regulatory changes or guidance in best practices that may impact our programs.
  

Requirements

• 3 years experience in 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.
  

The company is well known for its strong ethics and good working conditions with 20 days annual vacation plus all local public holidays and the usual benefits like 401k and health insurance contributions.