QC Program Manager
Are you passionate about Customer Engagement and Program Management? Then you might be our new QC Program Manager.
About the role
The role demands the manager to operate on both a strategic level with senior executives and to facilitate operational elements in the actual program execution. It requires a personality that induce sufficient business acumen and process insight to drive, facilitate, and manage stakeholders across the entire business with authority and charisma.
The position enables build-up of strong insight to our business, build-up of network both internally and with costumers.
Your task and responsibilities among others will be to:
- Understand the customers need and requirements and act as primary QC contact for external customers and partners for all Fujifilm Diosynth Biotechnologies Denmark QC teams involved in the customer collaboration.
- Support initial meetings with customers together with Analytical technology for the technology transfer and Quality Control activities from a QC customer perspective.
- Lead, coordinate and facilitate customer meetings to ensure high performance of QC activities
- Operational meetings to ensure normal operational activities
- Quality management meetings where relevant Key Performance Indicators are shared
- Support the generation of contracts and amendments to these (Quality Agreement, Statement of Work, Master Service Agreement) together with the global Commercial Development team and Quality Assurance.
- Adhere to the global quality system and support handling of tasks in accordance with Statement of Works and Quality Agreement.
About the department
You will work closely with internal stakeholders in QC but also with Program Managers from other functions to ensure high performance on the different programs. You will be part of the QC Partner Management team that is part of the overall QC organization, that consists of approximately 90 employees divided into five testing groups and various support teams. We work in a busy and dynamic environment where we support the biologics Drug Substance (DS) production as well as the global release of commercial products (DS/DP) for our clients from all over the world.
Your qualifications and competences
- Degree in Natural Science
- Minimum 2 years relevant QA or QC experience from the pharmaceutical industry. Manufacturing experience will be beneficial
- Knowledge of GMP quality systems
- As a person, you are organized with an attention to detail and still able to keep an overview
- You are service minded with excellent verbal and oral communication skills
- You have an ability to work independently
- You are a team player
- You thrive in a changing environment
- You like to multitask
Please upload your CV and cover letter as soon as possible and latest by 30Nov2020.
FUJIFILM Diosynth Biotechnologies is an industry-leading biologics Contract Development and Manufacturing Organization (CDMO) with locations in Teesside, UK, RTP, North Carolina, College Station, Texas and Hillerød, Denmark. 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.
Our manufacturing site in Hillerød, Denmark, brings together a complete range of expertise, capabilities and technologies to manufacture advanced biologics. Our large scale manufacturing facility has a capacity of 120,000 liters to reliably manufacture biologics for late phase and commercial use. The facility for medical device assembly, labeling and packaging manufactures advanced delivery systems and ensures required labeling and secure packaging of the therapies for patients worldwide. The site also houses quality control laboratories, warehouses, and a number of organizations, supporting the manufacturing activities: process science, supply chain management, engineering and quality assurance. On June 9, 2020 FUJIFILM Corporation has announced the investment of approx. 6 billion Danish kroner into the site to double the manufacturing capacity, to add a fill finish capacity and to enhance the assembly, label and pack services on site. The investment is expected to create approx. 300 new jobs.
At FUJIFILM Diosynth Biotechnologies, you will gain hands-on experience in an industry-leading biologics contract development and manufacturing organization. You will work with highly-skilled and experienced professionals of different nationalities and backgrounds, engaging in challenging work by delivering solutions for the biopharmaceutical industry. We aim to foster a collaborative, innovative, diverse and rewarding environment, where it is possible to develop and learn. We pursue our fullest potential as individual contributors and team members. As part of our team, everyone is a valuable 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.