Senior Compliance Partner, Manufacturing
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Søborg
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:
” Working at FeMD offers you career opportunities that are difficult to find elsewhere. In this specific role as our new SCP, you’ll have the possibility of great impact on our compliance level and to decide the direction. Your efforts are directly reflected in results, and you will be working together with many different stakeholders in a versatile working day. I look forward to welcoming you as my new colleague.”
About Ferrosan Medical Devices
Ferrosan Medical Devices is a leading player in the medical devices industry, dedicated to providing innovative and high-quality solutions that improve patient outcomes. With a commitment to excellence and a focus on cutting-edge technology, we are at the forefront of advancing healthcare. Our products, used globally every second, exemplify our dedication to making a meaningful impact on the lives of patients around the world.
Rooted in our core values of care, own, and win, we foster a culture that prioritizes compassion, personal responsibility, and a winning spirit. These values are not just words; they are the guiding principles that shape our interactions and decisions and drive our pursuit of excellence in every aspect of our operations. The heartbeat of Ferrosan lies in our unwavering commitment to delivering superior medical solutions with care, taking ownership of our responsibilities, and consistently striving to win in the dynamic landscape of the medical devices industry.
Manufacturing at Ferrosan Medical Devices
Manufacturing in Ferrosan Medical Devices consists of approximately 140 people spread across key departments – two production departments, two Process Support teams, EHS and Technical Support, Utility & Facility. These departments work cohesively to ensure the seamless production and delivery of our cutting-edge medical devices, demonstrating a commitment to precision, efficiency, and continuous improvement adhering to Lean methodologies.
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.
Key Responsibilities
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.
To be successful in this role, you will probably:
Location
Søborg, Denmark
How to apply
Apply for the position by submitting your CV including your motivation no later than April 30, 2024.
We will process applications on an ongoing basis, so don't wait too long. The job ad will be reposted until the position is filled.
If you have any questions, please do not hesitate to contact the Director of Manufacturing,
Sune Vendelboe-Schack, at +45 53 66 49 48.
We look forward to hearing from you.
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:
” Working at FeMD offers you career opportunities that are difficult to find elsewhere. In this specific role as our new SCP, you’ll have the possibility of great impact on our compliance level and to decide the direction. Your efforts are directly reflected in results, and you will be working together with many different stakeholders in a versatile working day. I look forward to welcoming you as my new colleague.”
About Ferrosan Medical Devices
Ferrosan Medical Devices is a leading player in the medical devices industry, dedicated to providing innovative and high-quality solutions that improve patient outcomes. With a commitment to excellence and a focus on cutting-edge technology, we are at the forefront of advancing healthcare. Our products, used globally every second, exemplify our dedication to making a meaningful impact on the lives of patients around the world.
Rooted in our core values of care, own, and win, we foster a culture that prioritizes compassion, personal responsibility, and a winning spirit. These values are not just words; they are the guiding principles that shape our interactions and decisions and drive our pursuit of excellence in every aspect of our operations. The heartbeat of Ferrosan lies in our unwavering commitment to delivering superior medical solutions with care, taking ownership of our responsibilities, and consistently striving to win in the dynamic landscape of the medical devices industry.
Manufacturing at Ferrosan Medical Devices
Manufacturing in Ferrosan Medical Devices consists of approximately 140 people spread across key departments – two production departments, two Process Support teams, EHS and Technical Support, Utility & Facility. These departments work cohesively to ensure the seamless production and delivery of our cutting-edge medical devices, demonstrating a commitment to precision, efficiency, and continuous improvement adhering to Lean methodologies.
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.
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.
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.
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.
Location
Søborg, Denmark
How to apply
Apply for the position by submitting your CV including your motivation no later than April 30, 2024.
We will process applications on an ongoing basis, so don't wait too long. The job ad will be reposted until the position is filled.
If you have any questions, please do not hesitate to contact the Director of Manufacturing,
Sune Vendelboe-Schack, at +45 53 66 49 48.
We look forward to hearing from you.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 11.3.2024, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Øvrige
- Søborg
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