Head of Regulatory Affairs, Audits & Supplier Quality

For our site in Hillerød we are looking for a Head of Regulatory Affairs, Audits & Supplier Quality to lead a team of people ensuring Regulatory, Supplier Quality and Audit support to the organization both locally, globally and towards partners.

In this new role you will design and implement the proper business processes to form the basis for safe and compliant operations throughout the functions in Hillerød, including continuous monitoring and visualization of regulatory intelligence.

You will design and build out programs for supplier qualification to promote a highly sustainable supply chain of raw materials and components in the right quality and time, including build on an excellent history of inspections for the site and a robust internal and external audit program to further advance our business processes for executing inspections, partner audits, as well as internal and external audits.

Responsibilities

  • Leadership of highly skilled experts within the field of Regulatory Affairs, Supplier Quality and Audits
  • Regulatory sparring towards FujiFilm Diosynth Biotechnologies network and partners and contact to regulatory agencies, including keeping site and global network updated on regulatory intelligence
  • As a member of the site Quality/Regulatory leadership team engaging in the continuous improvement of Quality & Regulatory business processes and be a role model for the quality mind set
  • Building and maintaining strong network to internal key partners in Hillerød and globally as well as to external partners and customers

Qualifications

As a leader you have experienced that relations matter and you have a track record of building teams where each member feel they belong and that they are able to be the best version of themselves. You speak up and are curious to understand why we set the priorities as we do and you are relentless in understanding the meaning of your work. You are passionate about what you do and you are good at communicating to internal and external stakeholders as well as to your team.

Are you the leader that can:

  • Make regulatory affairs a competitive advantage – providing internal and external stakeholders with regulatory guidance to enhance opportunities for getting safe and effective high quality product to the market in high speed
  • Take supplier qualification to the next level and form the basis so that by partnering with suppliers we build a sustainable supply chain of raw materials and components in the right quality and time
  • Build on an excellent history of inspections for the site and a robust internal and external audit program to further advance our business processes for executing inspections, partner audits, as well as internal and external audits

Then you are the person that we are looking for to join our Quality leadership team where your peers are three enthusiastic leaders with a great passion for our people and our products. In the position as Head of Regulatory Affairs, Audits & Supplier Quality you will report to the Site Head of Quality & Regulatory Affairs.

The ideal candidate:

  • Has a Master degree in Life Science, Pharmacy or similar
  • Has regulatory knowledge to an extend that they can act as sparring to regulatory people in our partner relations until the knowledge is built in the team
  • Has 10+ years of leadership experience, leadership of people as well as external stakeholders and regulatory agencies
  • Is seeking to identify and build on people’s strengths
  • Is a person that others want to follow and an excellent listener and communicator
  • Believes that people are best if they love what they do

If you would like to join a highly dynamic site in a company with an aggressive growth strategy and a strong set of values please do not hesitate to send your application. We will interview during the month of October so if you are the right candidate please upload your CV and cover letter as soon as possible.

For more information about this role please contact Talent Acquisition Lead Eva Op De Beeck at +45 7221 0860.

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FUJIFILM Diosynth Biotechnologies is a world leading cGMP Contract Development and
Manufacturing Organisation (CDMO) with over 25 years’ experience. As a world leading CDMO we combine technical leadership in cell culture, microbial fermentation and gene therapies with state of the art GMP manufacturing, from our network of four global locations in the USA, UK and DK. We currently employ over 2,000 dedicated staff who have a reputation for excellent customer service, flexibility and responsiveness.

As part of FUJIFILM Diosynth Biotechnologies , you will be an active contributor in the advancement of tomorrow’s medicine. We take pride in enriching our communities, caring for our environment and cultivating a world of opportunity for future generations. We invest in you and what you care about, getting the right work-life balance for your health, you family and your professional growth.

FUJIFILM Diosynth Biotechnologies offers a healthy work environment that promotes
individual responsibility, allowing you to grow and progress. We support our employees with
programs that motivate and educate, promoting a healthy work-life balance that ultimately
increases personal well-being and employee satisfaction.