GXP Compliance Specialist

Do you thrive in an environment where stakeholder relations are key?

And do you work with an important level of independence?

Then we hope you will join our service-minded Supply Chain Team as soon as possible!

We are looking for a new colleague to help us provide the best support in all compliance GMP related matters.

Your New Role
You will join a well established Supply Chain, GxP Master Data Chain Compliance Team of currently six people. The Team is part of a larger team managing SAP Master Data and Digital Collaboration/Integration (15 people). The entire Supply Chain Department consist of 60+ dedicated and brilliant colleagues.

Main tasks

Deviations:

• Initiate and coordinate Deviations (Deviation Management)
• Lead/perform Root Cause investigations when required for deviations exceptions impacting warehouses, 3PL and other Supply Chain processes
• Initiate and coordinate Supplier Complaints (Vendor Complaints)
• Support the Customer Complaints process.
• Establish and implement corrective and preventive actions to mitigate risks, prevent re-occurrence and improve compliance.
• Track and trend on deviations and the efficacy of corrective/preventive actions.
• Support deviation management to ensure timely action and closure of records.

Change Control:

• Initiate and coordinate Change Controls (Change Management) and assess impact/risk of exceptions and Change Management Requests impacting Supply Chain processes, including warehouses and 3PL.
• Initiate and coordinate VCNs (Vendor Change Notifications)
• Lead investigations when required for exceptions impacting warehouse and other Supply Chain processes

Compliance:

• Guidance and support to Stakeholders regarding GDP
• Guidance and support to Stakeholders regarding GMP
• Ensure compliance of Supply Chain GMP Documents and improvement of the compliance level of Supply Chain processes in accordance with the requirements defined in the Pharmaceutical Quality System (PQS)
• Facilitate GMP/GDP awareness/re-fresher Training sessions within Supply Chain
• Track and trend on exceptions and efficacy of corrective actions and support management to ensure timely action and closure of records.
• Establish and implement corrective and preventive actions to mitigate risks, prevent re-occurrence and improve compliance.
• Support the Customer Complaints process
• Support Supply Chain preparation for audits and inspections.
• Support optimization projects and drive smaller optimization projects to ensure continuous improvement (Cis) of Supply Chain processes.
• Key quality systems superuser representing Supply Chain, working in close cooperation with the Quality Assurance Department to ensure alignment on interpretation of GMP issues.
• Support compliant Supply Chain Business Process Development

Skills & Knowledge, we hope you possess

• Bachelor or master’s degree within Pharmaceutical Sciences, Process Engineering, or similar area
• Preferred is a minimum of 2 years of GMP and compliance experience from the Pharmaceutical or Biotech industry. Warehouse, 3PL and Vendor compliance experience preferred.
• Work independently on compliance related issues, deviations, Change Controls, and smaller optimization projects.
• Knowledge and experience with the interface/interaction between Supply Chain, QA, and Manufacturing.
• Excellent level of technical writing skills and excellent communication skills in English and Danish (spoken and written).

We hope you are
Energized, goal oriented and initiative driven. We hope you thrive working 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.

Your New Team & Department
You will be part of a trusted & competent team within Supply Chain that covers Planning, Sourcing, Strategic Planning & Analytics, Logistic/Shipping, Vendor Changes and Complaints, SAP Master Data, and Warehousing.

Supply Chain Compliance supports all Supply Chain teams with the handling of deviations and CAPA's, document updates, changes controls, internal/external audits, optimization & tech transfer projects. In addition to our colleagues in Supply Chain, we have close collaboration with internal customers spanning across the site, participating and, in some cases, coordinating many cross functional assignments.

The work environment is international and informal. We keep a high pace and focus on a vital 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 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 Ass. Manager, Supply Chain GxP Compliance, 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.

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, colour, 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.

Location: FDBD Hillerod