Project Quality Assurance Specialist

Do you want to have an extensive influence and add your footprint on our future Drug Product Facility at FUJIFILM Diosynth Biotechnologies in Hillerød (FDBD)? Do you have experience with Fill Finish area and construction projects?

We are looking for a QA professional to join our (ongoing) Drug Product (DP) manufacturing project. In the first part of the journey, you will manage Project Quality Assurance (PQA) activities taking up the PQA Lead role to support the implementation of a new DP facility. When the project is implemented, you will transition to the daily DP QA operations team.

About the Department and Project Team
The DP QA Operations team is currently based under the Project Quality Assurance organization. Together, we shape the QA mindset for the future and the work environment is informal and with a good sense of humor, while keeping a high pace. Within the DP QA team there are QA ops personnel that supports the “Operational Readiness” part of DP project and there are project QA’s focusing on facility and equipment implementation. As a team, We are deeply committed and takes great pride in working with all types and levels of stakeholders.

About the Role
As the DP project QA lead, you will manage the project QA team that consists of two skilled QA specialists and 1-2 QA consultant supporting the commissioning, qualification, and validation activities of the DP project in Hillerød. You will work close together with the other project leads from other disciplines such as engineering, construction, CQV and automation. You will also be the responsible QA on one of the major process equipment packages such as the isolator-based filling line. In the DP project there is a respectful and safe atmosphere where open and honest communication and high level of agility is a reality.

After facility/equipment commissioning and IQ/OQ/PQ you will continue working in the team who will have Quality Oversight of the DP facility operations and all other Quality related activities.

Job Responsibilities
Your primary tasks while working as Project QA Lead will be:

• Lead up the DP Project QA (PQA) through SAT, IQ, OQ and PQ activities.
• Be very visible in the project and DP organization and therefore have strong stakeholder management skills.
• Create, approve and maintain quality plans and procedures.
• Continuous align with CQV Project Lead on CQV process to be utilized on the project with consideration given to ASTM E250 and leveraging from FAT into IOQ.
• Review and approve updates to Validation Project Plans covering Process-and support equipment IT/Automation, clean utilities and facility.
• Lead the reporting of Vendor Performance Evaluations (initial assessments and approvals are completed)
• Aligning with the DP Project Manager and project leads on requirements, maintain and manage PQA team for the duration of the project, both planning and forecast costing for the team.
• Ensure PQA pre-approval on all direct impact documentation to fully align with the project’s leveraging philosophy.
• Review and approve SAT/IQ/OQ and PQ for major process equipment e.g. filling line or automatic inspection machine
• QA involvement in clean room area readiness and qualification
• Oversight over project change management planning and execution
• Involvement in internal Mock-up audits to prepare for GMP inspection.

Qualifications

• You hold a Master of Science within Pharmacy, Biotechnology, Biology, Technical Engineering or similar.
• You have +5 years of QA for engineering/validation experience including experience with design and construction projects, preferable with fill-finish equipment and facility.
• Strong leadership skills with knowledge on how to set the direction for the project regarding quality.
• Working knowledge of principles, concepts, and practices of ASTM E2500/Leveraging Verification process.
• Deep cGMP knowledge.
• Fluent in English both verbally and in writing.

Personal skills

• Ability to keep work pace and meet deadlines. Good organizing and planning skills.
• Self-starting and have a flexible, dynamic approach to work.
• Attention to details yet keeping the overall picture of the project.
• You communicate in a proactive and solution-focused manner and function well in a cross-functional team environment.
• As a person you enjoy a fast paced and changing environment.
• You are a team player who is motivated by working in a dynamic environment with a strong focus on providing support to both colleagues and stakeholders.

Your Application
Has this sparked your interest? Then we urge you to upload your CV and cover letter in English 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 DP Manager in Quality Assurance Maria Louise Olsen on marialouise.olsen@fujifilm.com

About FUJIFILM Diosynth Biotechnologies
FUJIFILM Diosynth Biotechnologies, a subsidiary of FUJIFILM Corporation, is a world-leading contract development and manufacturing organization (CDMO) with experience in the development and manufacture of biologics, vaccines and advanced therapies The company operates a global network with major locations in the Unites States of America, the United Kingdom and Denmark and it is building a new manufacturing site in Holly Springs, North Carolina, USA.

FUJIFILM Diosynth Biotechnologies has over thirty years of experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules, viral products and medical countermeasures expressed in a wide array of microbial, mammalian, and host/virus systems. The company offers a comprehensive list of services from cell line development using its proprietary pAVEway™ microbial and Apollo™X cell line systems to process development, analytical development, clinical and FDA-approved commercial manufacturing.

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.

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