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QA Drug Substance Operations Associate Manager

FUJIFILM Diosynth Biotechnologies



This is a unique position as the Team Lead for our Biological Drug Substance QA team. We are looking for a Team Lead for both our Upstream and Downstream QA teams. The Biological Drug Substance QA teams supports QA operations for our Drug Substance facility from Tech Transfer to releasing the product with focus on the process, equipment, and the digitalization hereof.

Do you thrive in an environment where you have a highly competent team to lead and work with? Do you get energized by discussing ways to improve with your colleagues? Then this might be the job for you.

About the Role
Our work with a myriad of biopharma companies means each project we work on, brings a unique set of challenges. As Drug Substance QA Team Lead, you are supporting a team where focus must be to enforce TRUST with our internal stakeholders and external customers via our high compliance level. Furthermore, we are in the process of expanding our facility and will more than double our capacity.

Your primary tasks will be:

  • Lead, motivate and help prioritize the tasks for the team
  • Support and develop the team members for both business and personal growth
  • Promote identification and implementation of improvements and facilitate building of new processes where necessary
  • Represent the team and organization in cross-functional collaborations
  • Engage in our QA Supporting Manager team as well as the entire QA management team
  • The role is based in Hillerød, Denmark and you will report to the Manger in QA DS Operations
  • The work environment is informal, where we strive to have a lot of fun while we learn and develop

Qualifications
You are known to be an open, positive, and curious person who prefers a set of good and complex challenges over a routine heavy workday. You understand how to drive daily operations of a team, but just as importantly when to collaborate with your colleagues and connect to ensure direction.

You get energetic from connecting dots – and people, and from optimizing processes and strengthening collaborations. You understand the gift of diversity in a team and know how to utilize different competencies and perspectives.

You have experience with transformations; maybe you have worked in a company or an organization which was growing fast and had to make major adjustments or maybe you have lead transformations and know how to bring people all the way to the new reality.

From your experience in the pharmaceutical industry, you possess a fundamental understanding of quality and compliance. This background enables you to effectively assess and prioritize tasks without compromising the business.

You are an open and visionary leader, who always has time for challenging, arguing and supporting your team and topics. Moreover, we expect that you:

  • Have experience as a team leader in the pharma industry - QA management is an advantage
  • 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 solution for all
  • Stay calm in challenging situations to facilitate the right decisions are made.
  • Think out of the box and challenge the status quo
  • Be a part of DS QA Operations management team and support the area in moving in the right strategic direction
  • You have good communication skills and are fluent in English

Application
Has this sparked your interest? Then we urge you to please upload your CV and cover letter.

Due to the upcoming vacation period, interviews will be scheduled to take place in August.

Should you have any questions, please feel free to reach out to the Managers in DS QA Operations:

Lotte Risom (Downstream) [email protected]

Alexander Overby (Upstream) [email protected]

Working at FUJIFILM Diosynth Biotechnologies
We offer a competitive compensation package in a site/company growing rapidly, with many opportunities for individual growth, we also offer access to fitness and an attractive canteen.

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.

Location: FDBD Hillerod

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FUJIFILM Diosynth Biotechnologies

Biogen Alle 1, 3400 Hillerød

A global CDMO in pharmaceutical manufacturing providing process development and cGMP production in cell culture, microbial fermentation and gene therapies


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