Senior Compliance Partner, Manufacturing

at  Ferrosan Medical Devices

INTRODUCTION

As our current Senior Compliance Partner (SCP) soon will be taking on a new role following an internal promotion, we are now looking for a new dynamic and results-oriented SCP to join our management team for Manufacturing. The soon-to-be former SCP, Camilla Kromann, says the following about the job:

POSITION OVERVIEW

In this role, the SCP will report directly to the Director of Manufacturing and serve as a trusted partner in all GMP, quality and compliance related issues for all departments in Manufacturing. The SCP will play a pivotal role in raising the bar for the overall quality level and ensuring a high level of compliance. In this role, you will work together with many different internal stakeholders across the site, and you will have the opportunity to influence the business and make a significant impact in the Manufacturing area.

QUALIFICATIONS

As you will be working with an array of different functions within Ferrosan Medical Devices, it is important that you have excellent teamworking skills. You must be able to work in a structured and analytical way. To be successful in the job it is important to be able to collaborate with colleagues in different functions. You will also be responsible for tasks that require you to work on your own and without detailed instruction – which is why your ability to take initiative and have overview is a key trait in your professional toolbox. You are structured, with a strong quality mindset and able to finish tasks before the deadline. You thrive working independently and in groups across departments and organizations and you are confident with challenging stakeholders at different levels.

KEY RESPONSIBILITIES

• Prepare, participate in, and follow up on internal and external audits/inspections.
• Identify compliance gaps and participate in compliance projects that aim to close compliance gaps.
• Coach and train employees in GMP-related tasks, e.g. deviations, CR cases, qualifications, and validations.
• Follow up on and act on quality data trends.
• Follow up on relevant KPIs.
• Prepare/draft, participate in and follow up on the Quality management review (QMR).
• Participate in and follow up on actions from the compliance network in FeMD.
• Participate in projects and run smaller compliance projects.
• Facilitate systematic problem solving and handling of deviations.
• Develop and optimize procedures and instructions.

TO BE SUCCESSFUL IN THIS ROLE, YOU WILL PROBABLY:

• Hold an academic degree in Engineering, Chemistry, Biotech, Pharmacy or similar.
• Be experienced within a GMP-regulated production environment.
• Be experienced with analyzing data and applying it to problem solving and procedure development.
• Be familiar with writing documents and procedures in adherence to current regulations.
• Be experienced with audit preparation and execution.
• Have exceptional collaboration- & stakeholder management skills
• Have good analytical skills.
• Speak and write English and Danish fluently.