Supply Chain GxP Compliance Specialist

Do you thrive in an environment where stakeholder relations are key, and do you work with a high level of independence and good GMP knowledge regarding risk-based approaches? Then come and join our service minded GXP Compliance Team as soon as possible!

We are looking for a new colleague to help us provide the best support in all compliance GxP/GMP related matters. We oversee the entire Supply Chain and in addition we have close collaboration with internal customers spanning across the site, participating and, in some cases, coordinating many cross functional assignments.

Your New Role & Future Tasks

You will contribute with your knowledge and personality to the daily compliance support to our stakeholders.

• Guidance in, support and training regarding GMP/GDP. Is this a deviation, how to proceed with this finding, is just some of the question you can get from our stakeholders.
• Ensure compliance of Supply Chain GMP Documents and improvement of the compliance level of Supply Chain processes.
• Support Supply Chain preparation for audits and inspections.
• Support and drive smaller and bigger optimization projects to ensure continuous improvement (CIs) of Supply Chain processes
  
  
  

You can look into the further process steps and reach out to different stakeholders in your work with deviations.

• You will have to initiate, coordinate and sometimes investigate deviations for Warehouses, 3PL and other Supply Chain processes.
• You will initiate, coordinate and support Supplier- and Customer Complaints.
• You will have to establish and implement corrective and preventive actions (CAPA) to mitigate risks, prevent re-occurrence, all in close cooperation with our stakeholder.
• You will do track and trend on exceptions and efficacy of corrective/preventive actions and support management to ensure timely action and closure of records.
  
  
  

You must use your helicopter perspective in your work related to Change Control incl. Vendor Change Management:

• Initiate and coordinate Change Control (Change Management)
• Provide impact/risk assessment of the Change Control, collect SME input and impact assessment/s.
• Initiate and coordinate VCNs (Vendor Change Notifications) to ensure compliance with Regulatory requirements.
  
  
  

Education And Qualifications

• Bachelor’s or master’s degree within Pharmaceutical Sciences or similar area
• Preferred is a minimum of 2 years of GMP and compliance experience from the Pharmaceutical or Biotech industry. Experience with Vendor (Supplier) Change Management and Warehouse compliance is preferred.
• You can work independently on compliance related issues, deviations, and optimization projects.
• You have knowledge and experience with the interface between Supply Chain, QA, Manufacturing, and Suppliers.
• You have a good level of technical writing skills and excellent communication skills in English and Danish (spoken and written).
  
  
  

As a Person We Hope

• You are energized and open to change and have a good knowledge of GXP compliance impact.
• You are initiative driven and thrive in a dynamic environment.
• You can work independently and are able to prioritize your tasks and meet your deadlines.
• You work analytically and structured with a quality mind set while being able to see the big picture in the tasks.
• You go to people with a Genki attitude and can work together with people in all level of the organization.
  
  
  

Your New Team & Department 

You will be part of a highly trusted & competent team within Supply Chain, which consists of 60+ dedicated and brilliant colleagues.

Supply Chain covers Planning, Sourcing, Strategic Planning & Analytics, SAP Master Data, Program Management, Warehousing, and shipping & Customer Service.

The work environment is international and informal. We keep a high pace and focus on a vital work life balance while having fun. We put a strong emphasis on psychological safety through trust and empowerment within our teams and hope that this is something that speaks to you as well.

Application

Has this sparked your interest? Then we encourage you to please upload your CV and cover letter as soon as possible, as we screen candidates on a continuous basis and call in for interviews.

If you have any questions, please do not hesitate to contact Supply Chain GxP Compliance Manager Susanne Madsen +45 20743332

FUJIFILM Diosynth Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Hillerød, Denmark, Teesside, UK, RTP, North Carolina and College Station, Texas, USA. We use our skills, dedication and ambition to enable impact for the world’s most innovative biotech and biopharma companies reimagining healthcare’s potential. We work across the entire lifecycle of our customers’ products – enabling success throughout. Every cure, vaccine, biologic, and advancement we contribute to starts with our people and our passion. We fuel one another’s passion, help accelerate progress, expand capabilities, strengthen innovation, and improve processes to improve lives.

Our Manufacturing site in Hillerød, Denmark, brings together a complete range of expertise, capabilities and technologies to manufacture advanced biologics. As we continue to enhance and expand our capabilities, we are looking for people who share our passion, drive, and energy – what we call Genki – to join our team.

We offer the chance to be part of a global workplace where passion, drive and commitment are met with opportunities for professional and personal development. Deeply committed to diversity and inclusion, we ensure that everyone no matter their background or gender has an opportunity to develop. We take pride in enriching our communities, caring for our environment, and cultivating a world of opportunity for future generations.

We aim to foster a collaborative, innovative and rewarding environment, where diverse perspectives and people come together united by a common purpose and shared values. We pursue our fullest potential as individual contributors and team members. We strive to be the employer of choice and offer a competitive compensation and benefit package.

FUJIFILM Diosynth Biotechnologies Denmark (FDBD) is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation, gender identify or any other protected class.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.