Customer Program Quality Manager
5 days ago
Customer Program Quality Manager - Tech Transfer and Quality Agreements
Customer Program Quality Manager - Tech Transfer and Quality AgreementsApply locations Hillerod time type Full time posted on Posted 30+ Days Ago job requisition id JR3645
Do you have QA experience from manufacturing (Drug Substance/Drug Product/Finished Goods)? Are you interested in ensuring the right Quality level to our customers and keep them updated around the manufacturing of their products? Then you might be the key person we are looking for
Come and join the Program Quality Management team for Manufacturing (PQM MFG) at FUJIFILM Diosynth Biotechnologies and play an important role in the relationship with our customers. With a fast-expanding site, our team is growing to support our increased number of customers. The PQM MFG team is accountable for the communication of all quality related topics affecting customer’s programs for production of Drug Substance, Drug Product and Finished goods. The communication is based on the responsibilities defined in Quality Agreement (QUAG).
About the Position
We work with various biopharma companies, which means each project we work on brings a unique set of challenges. As a PQM Tech Transfer lead, you are the link between our customers and our FDB team.
You will be involved in all quality related topics related to the Tech Transfer affecting customer’s programs and make sure customers are informed and involved to feel confidence in our collaboration. You will interact with highly skilled personnel to support your communication on complex activities. We continuously strive to identify opportunities to improve systems and practices and provide direction to our manufacturing group as well as technical development teams and our customers. You represent our company: our mission of advancing tomorrow’s medicine, our passion for collaborating with our partners for life, and our dedication to seeing every project through with the highest amount of integrity and impact.
Job Responsibilities
Your primary tasks:
- Be the primary point of contact regarding quality assurance when onboarding new customers
- Be the primary point of contact to customers regarding quality related topics to the Tech Transfer process
- Drive discussions with customers to establish new Quality Agreements as well as continuous revision of existing Quality Agreements
- Support Technical Transfers/Process Performance Qualifications manufacturing activities including representing quality assurance in the core team for the program
- Prepare and participate in customer visits in relation to Tech Transfer
- Establish, develop and maintain department documents: customer presentations, SOPS and participate in our internal Continuous Improvement activities
- Ad hoc tasks
About the Department/Team
The Program Quality Management (MFG) team consists of 8 highly skilled and dedicated team members with broad experience within pharmaceutical manufacturing. The team is an organization embedded in the Quality organization under Program Quality and provides quality support to production of engineering, clinical, PPQ and commercial batches in large scale Drug Substance manufacturing, filling of Drug Product and Assembly, Label and Pack.
Professional and Personal Qualifications
The candidate holds a master’s degree in Biochemistry, Biology, Biotechnology, Pharmaceutical Sciences or similar with interest and knowledge of GMP and quality systems with a minimum of 10 years of relevant QA experience. Experience with establishment and negotiation of Quality Agreements is preferred.
As a person you approach tasks and colleagues with openness and great energy. You possess a structured mindset and understand the importance of involving stakeholders in your daily work. You are a self-starter and have a flexible, dynamic approach to work. You are service minded with excellent verbal and oral communication skills. Fluency in English is required as English is our corporate language.
Application
Has this sparked your interest? Then we urge you to send an updated CV and cover letter as soon as possible. We will continuously invite relevant candidates for job interviews and will close the position as soon as we have found the right candidate.
In case you have any questions, please do not hesitate to contact Head of Program Quality Management, Manufacturing, Annelise Olsen +45 41945471.
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