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Global Internal Audit Manager

Brønshøj, Copenhagen
BRIEF COMPANY PROFILE
Our client is a global leading provider of technologically advanced acute care solutions that simplify and automate all phases of acute care testing. The company’s advanced solutions and products help healthcare professionals get fast and accurate information on the most critical parameters in acute care testing. This is the foundation for making immediate and well-informed decisions on the treatment of critically ill patients in clinical settings such as emergency care, intensive care, anesthesiology, cardiac surgery, neonatal care and wound care.

The company is located in Greater Copenhagen.
 
THE POSITION
The Internal Audit Manager will be a part of an international team of highly skilled and engaged colleagues and will collaborate closely with QA counterparts in the company’s global manufacturing sites. The role will set the direction for the global internal auditing effort and ensure overall internal audit coordination. Additionally, the role will be responsible for supporting and training international auditors in the company with the purpose of an alignment of company QMS standards, while being a vital support function in the company’s external audits.
The role will be responsible for ensuring that the internal audit process – both locally and globally - is managed and conducted in accordance with applicable standards and regulations, to drive optimization of the internal audit process and to support the organizations locally as well as globally. Additionally, the role is responsible for planning and hosting external audits. Finally, the role must provide a strategic overview of audit processes while ensuring QMS improvements across manufacturing sites and thereby enabling standardization on principles, processes & practices.
 
 
POSITION PROFILE
Position title:
 
Internal Audit Manager
Reporting line:
 
Senior Director, Global QMS Compliance
Location: Greater Copenhagen.
   
Traveling: Limited.
   
Responsibilities & Tasks:
 
  • Driving and maintaining optimization of the global as well as the local Internal Audit Process at the company as process owner and Global Internal Audit Team Coordinator.
  • Conducting global/local Internal Audits.
  • Guiding the organization during External Audits.
  • Sharing knowledge and maintaining expertise within applicable standards and regulations.
  • Planning, facilitating, conducting training of the organization.
  • Reporting on appropriate process metrics.
  • Participating in and driving smaller projects in the RA/QA function with manageable risks and resource requirements.
  • Training and supporting the company’s auditors globally.
   
Key success criteria:
 
  • Managing and planning internal audit processes in collaboration with global stakeholders from company manufacturing sites ensuring all sites are focusing on QMS improvements in accordance with applicable standards.
  • Successfully contributing to continuous improvement and a high-performance, with a focus on delivering customer-centric solutions to meet current and anticipated needs.
  • Successfully driving broad cross-functional stakeholder collaborations, alignment and communication.
 
CANDIDATE PROFILE
Educational background: Degree preferably at M.Sc.-level within Science, Engineering, Pharmacy, Biology, Biochemistry or the like.
   
Language: English and Danish – fluent (verbally and written).
   
Ideal experience:
  • 5+ years of in-depth knowledge and experience with applicable standards and regulatory requirements (ISO 13485, IVD, MDD, and FDA legislation) from QA job function.
  • Expertise leading internal audits and hosting external audits incl. experience with Front Office / Back Office roles.
  • Profound knowledge of and experience with best practices within Quality Management System(s) from the Medical Devices/Diagnostics space.
  • Experienced lead auditor with profound project management abilities.
  • Proven track record with problem-solving and continuous improvements.
   
Personal- & leadership competencies: Structure
Works systematically and is highly organized and methodical, while displaying perseverance and consistency towards commenced responsibilities, tasks and projects.


Take control/responsibility
Positive, open-minded and proactive mind-set; makes sure employees/co-workers have a clear understanding of the direction of the tasks; takes action; organizes resources and direct others toward successful execution of the tasks; drives projects forward to reach pivotal objectives; makes things happen and follows through.


Robust
Is vigorous, shows strength and displays stress-tolerant behaviour.


Planning

Plans a focused course of action for himself/herself and others, ensures an appropriate assignment of tasks for employees, schedules an optimal use of the available resources.


Independent
Is independent, self-assured, has a realistic belief in own abilities to take suitable measures in the execution of tasks, expects success regarding own initiatives, able to maintain momentum in case of adversity.


Continuous improvement
Champions the philosophy of continuous improvement with a high degree of integrity fostering transparency, reliability and trustworthiness – personally and professionally.

Stakeholder Management
Is able to establish and maintain relations with people at all levels internally as well as externally and make people feel at ease. Achieves agreement by dealing with disagreements and potential conflicts with diplomatic skills. Develops and maintains networks.


Analysis
Divides problems into relevant parts; sensitively integrates the analytical output into the given context; differentiates between key areas and irrelevant and less important areas; has a logical mind-set; makes sensible decisions on the basis of available information; is able to get an overview of a specific situation and at the same time work detailed with a problem; uses details to gain an overview of a situation.


Coordination
Coordinates activities and delegates responsibility to the relevant co-workers and allows them room for manoeuvre to explore own initiatives, empowers people in order for them to carry out tasks efficiently.

 

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