FUJIFILM - Drug Substance QP Disposition Manager

This is a unique position where you will be the Manager for our Biological Drug Substance Disposition team. The Biological Drug Substance Disposition team is supporting QA operations for our Drug Substance facility from Tech Transfer to releasing the product.

Follow Your Genki to FUJIFILM Diosynth Biotechnologies

The work we do at FUJIFILM Diosynth Biotechnologies (FDB) has never been more important—and we are looking for talented candidates to join us. We’re growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help create the cure or great treatment in partnership with some of the most innovative biopharma companies across the globe. Here, you will work alongside and learn from some of the most dedicated scientists, engineers, and manufacturers in the industry. We are proud to cultivate a culture that will fuel your passion, energy, and drive — what FDB calls Genki. Join us and discover a community that thrives on diversity and never scares away from a complex challenge. At FDB, you determine what’s possible. Our Manufacturing site in Hillerød, Denmark, brings together a complete range of expertise, capabilities and technologies to manufacture advanced biologics for our customers.

About the Role

Do you thrive in an environment where you have a highly competent team to lead and spare with and together you will find the right compliant solution.

Our work with a myriad of biopharma companies means each project we work on brings a unique set of challenges. As DS QP Manager, you are supporting a team where focus must be to enforce TRUST with our customers via our high compliance level. Furthermore, we are in the process of expanding our facility and will double our capacity.

You are an open and visionary leader, that always have time to challenge, argue and support your team and topics. Moreover, we expect that you:

• Have experience from being a manager of a Disposition team (not necessarily in DS area)
• Have the extra bandwidth and show dedication and care for your team
• Are transparent in your communication, value open and honest dialogues– talking to the WHY
• Thrive in finding the right and compliant solutions for all
• Stay calm in challenging situations to ensure the decisions are made
• Think out of the box and challenge status quo

About the Department/Team

The Biological Drug Substance Disposition team is supporting QA operations for our Drug Substance facility from Tech Transfer to releasing the product (from engineering runs to commercial campaigns). The team is one of 3 QA operation teams supporting the Biological Drug Substance manufacturing and supporting functions and consist of 7 highly skilled and valued employees. The work environment is informal, where we strive to have a lot of fun, while we keep a high pace.

In addition, FDBD values the manager network across all functions, and you will have a closer network with your peers across the QA Operations Department. In our network, you will be able to share knowledge and experiences with your peers and this will allow you as a manager to exchange ideas about best practices and share your own learnings and experiences with our manager network.

Your primary tasks will be:

• Responsible for supervision of the DS QP team which includes planning, goals setting and supervising of personnel in accordance with the company strategy
• Through leadership and interactions with the key stakeholders to ensure the appropriate resources are in place for the group to be able to perform timely QA review and approval of batch documentation for DS. Maintain internal training level for the team and keep up to date on cGMPs and regulatory requirements as well as on global procedures, guidelines, policies, frames, and specifications as well as Quality Agreements for partner programs
• Ensure QA review and approval of exceptions and CAPAs. Perform review and Area Manager approval of documentation in the QA DSM Operation department, when required. Ensure timely review and approval of process performance qualification (PPQ) protocols and reports, continuous process monitoring protocols/reports, risk assessments and sampling plans and approve DS retain requests
• QA support in audits and inspections from competent authorities and external parties.
• Ensure QA support in technology transfer of new products manufactured in Hillerød site.
• QA support in collaboration with partners

Qualifications

We are looking for a candidate with the following background and skill sets:

Professional qualifications

• Is (delegated) QP or is manager for a disposition team or similar
• +3 years of experience being a People Manager
• Good communication skills and fluency in English
• Master of Science in a natural science, e.g. Pharmacy, Biothechnology, Biology or similar

Personal qualifications

As a person you approach tasks and colleagues with openness and great energy. You possess an analytical mindset and understand the importance of involving stakeholders in your daily work. You are self-starting and have a flexible, dynamic approach to work. Lastly, if you bring yourself to work every day and thrive in delivering together with your team and as ONE team, then you might be just the candidate, we are looking for!

Your application

Has this sparked your interest? Then we urge you to upload your CV and cover letter as soon as possible as we will be doing interviews on an ongoing basis and will take down the advert when we have found the right candidate.

In case you have any questions or doubts, please do not hesitate to reach out to Sr. Manager in Quality Assurance Mia Nielsen on mia.nielsen@fujifilm.com

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.

Application via website: https://fujifilmdiosynth.wd3.myworkdayjobs.com/en-US/External/details/Drug-Substance-QP-Disposition-Manager_JR1124