Delegated QP Drug Substance

Are you a skilled and experienced Quality Assurance specialist with project management skills and eager to join a fast-growing CDMO? Apply for this position where you will be an important part of developing and ensuring our quality aspiration.

About the Role
You will take on a role as a QA partner for all activities related to Drug Substance Manufacturing activities, daily operations, optimization projects, expansion programs and partner collaborations.

About the Department/Team
You will be part of the QA DS QP team. Currently the team consists of 10 dedicated QA’s that covers the Drug Substance Manufacturing operation and project activities, along with project related expansion activities. An independent and dynamic team in daily contact and in close collaboration with all internal stakeholders and QA colleagues.

Job Responsibilities
Your primary tasks will be:

• To manage QA optimizations projects
• To perform batch review and release activities, ensuring the batch has been manufactured and tested in accordance with accordance with GMP regulations, quality agreements and Marketing Authorizations
• Take on the QA role in technical transfer operations and approval of related change controls and documents
• To help maintain the quality system related to the exceptions and disposition processes based on the current GMP, GDP and regulatory requirements
• You will also support the quality assurance department with all relevant tasks, that being approval of procedures, deviations, change controls, CAPAs etc.

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

Professional qualifications

• University degree in pharmacy, medicine, veterinary science, pharmaceutical chemistry and technology, chemistry, biology or similar.
• Experience with GMP quality systems and legislation.
• Experience with optimization of processes.
• You have a high level of business perspective.

Personal qualifications

• Curious on process flows and optimization possibilities.
• Service minded.
• Proactive in your approach.
• Thrive in a changing environment.
• Enjoy working with multiple stakeholders in a large organization.

Application
Has this sparked your interest? Then we urge you to please upload your CV and cover letter as soon as possible as we will be doing interviews on an ongoing basis. Should you have any questions, please feel free to reach out to Manager in QA, Christina Schmidt at [email protected].

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