QP and Head of QA Drug Substance

Are you motivated to lead and inspire four dedicated QA Drug Substance teams within a rapidly growing CDMO? Fujifilm Diosynth Biotechnologies in Hillerød is looking for a proactive and passionate individual to take on the role of Head of QA Drug Substance. This position offers a unique opportunity to embody our core values of trust, customer satisfaction, Gemba (go see), and Genki (enthusiasm), steering our teams towards outstanding performance and innovation.

About the Role
As the Head of QA Drug Substance, you will be the critical link between our internal stakeholders and the QA DS management team on the tactical level. Furthermore, you will play a key role in the transition of the Drug Substance capacity expansion from project into operation. You must bridge the knowledge, QA communication, inspection support and manning. You will excel in building relationships with key stakeholders and cross-functional teams, ensuring seamless communication and rapid mastery of our quality assurance processes. Your high emotional intelligence, organizational skills, and ability to navigate ambiguity make you indispensable. Representing FDB, you will embody our mission to advance medicine and collaborate passionately with partners to achieve impactful outcomes.

You will be the QP on our license covering Drug Substance (biological API) batch confirmations.

Your will be part of a core team that consists of highly experienced QA colleagues covering all parts of the business.

The QA Drug Substance department is crucial to our operations at Fujifilm Diosynth Biotechnologies. As the Head of QA Drug Substance, you will lead a dedicated team of four highly professional managers with extensive experience in Drug substance manufacturing, primarily focused on monoclonal antibodies (mAbs). Your leadership will ensure the highest standards of quality and compliance, driving continuous improvement and fostering collaboration across all functions. Join us to play a pivotal role in advancing the future of medicine through quality assurance excellence.

Key Responsibilities

• Leadership: Lead and manage QA Drug Substance teams, fostering a culture of excellence and continuous improvement.
• Quality Assurance: Oversee all QA processes, ensuring compliance with global regulatory standards.
• Strategic Development: Develop and implement QA strategies and policies to enhance operational efficiency.
• Collaboration: Work with cross-functional teams to support seamless manufacturing processes.

Qualifications

• Educational Background: Master’s degree in Pharmacy or similar qualifications to meet the requirements of a Qualified Person.
• Experience: Over 10 years in biopharmaceutical production with significant QA experience and at least 10 years in a leadership role.
• Technical Skills: Expertise in QA principles, GMP regulations, and validation of production equipment and processes.
• Language Skills: Excellent communication skills and fluency in English.

Personal Attributes

• Strong leadership and team management capabilities.
• Analytical and problem-solving skills.
• Proactive and dynamic approach to work.
• High integrity and commitment to quality.

Application
Has this sparked your interest, then please upload your CV and cover letter.

The Company

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.

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