Quality Systems & Compliance Manager

Job Summary

Responsible for ensuring that internal and external audits are conducted following international regulations and standards requirements. 

This person adds value to the organization on the grounds it is also in charge of documental and change order module system improvements, so as they both meets their related standards. The overall role demands this partner to add value on the Quality System Management compliance.

Key Accountabilities

Conduct internal audits and participate in external ones

• Continuous improvement for the Quality System Management
• Plan, design and manage electronic document and record management system (EDRMS) ensuring GMP and specific ISO regulations compliance for electronic document and record management control system
• Optimize Change management system throughout the SAP change order module
• Ensure that all activities are performed accordingly to the Quality Management System
• Report metrics of the department 
• Provide guidance and monitoring to all direct reports
• Be capable of decide the priorities of the department
• Lead internal follow up meetings of the department
• Train the staff in the new processes or improvements related to Audits,  EDRMS or Change Order module capabilities.

Networking/Key relationships

To be determined based on department needs, to include interactions such as:

• All departments of the company
• Notified Bodies and Competent Authorities representatives
• Quality Systems and Compliance Werfen counterparts

Minimum Knowledge & Experience required for the position:

Education

• Required: Bachelor's degree in any related area with the business. 

• Valuable: Any additional degree higher than the required previously. 

Experience

• Professional experience is required, minimum of 5 years in a similar position.

Additional Skills/Knowledge

• Internal/External Audit expertise

• Software: deep expertise in Office Tools (mMcrosoft), required knowledge in SAP and EDRMS. 

• Language: Fluency in Spanish or Catalan. Advanced knowledge of English (reading and speaking).

• Standards: knowledge of Quality Regulations applicable to the company. 

Skills & Capabilities:

• Agile decision maker under pressure
• Methodical and well-organized person
• Teamwork
• Time management skills
• Ability to express information clearly and concisely to the staff, ensuring comprehension
• Ability to apply a systematic approach and constant control, follow-up and verification of the results
• Ability to collaborate, participate and coordinate actively with working groups
• Reflects values of Werfen in the quality of work and working relationship

Travel requirements:

• 5-10% of travelling time.