Manager QA for QC

Tytuł pracy:

Manager QA for QC

Firma

Fujifilm

Opis stanowiska

Do you thrive by having a highly competent team to lead and work with?Do you get energized by discussing ways to improve with your colleagues? Then this might be the job for you!As our production site grows, the testing activities expands which requires more Quality Oversight.We are looking for the right QA manager who would like to lead a positive, engaged and supporting team.Your New RoleThe QA for QC team supports the operations with tasks spanning from reviewing and approving QC relevant documentation (test method documentation, instrument qualification etc.) equipment alarms, changes and deviations.Our collaboration with a number of biopharma companies means each project we work on brings a unique set of challenges.As Manager for QA for QC, you are supporting a team where focus must be to enforce TRUST with our internal stakeholders and external customers via our high compliance level.Primary Responsibilities

• Responsible for supervision of the QA for QC team which includes planning, goals setting and supervising of personnel in accordance with the company strategy.
• Through leadership and interactions with the key stakeholders to ensure the appropriate resources are in place for the group to be able to perform timely QA review and approval of documentation and to provide proactive quality oversight of QC. Maintain internal training level for the team and keep up to date on cGMPs and regulatory requirements as well as on global procedures, guidelines, policies, frames, and specifications.
• QA support in audits and inspections from competent authorities and external parties.

Skills & Knowledge, we hope you possessYou are an open and visionary leader, who always has time for challenging, debating and supporting your team and topics. Moreover, we expect that you:

• Have experience as a manager in the pharma industry – QA management is an advantage

• Have the extra bandwidth and show dedication and care for your team

• Have good communication skills and fluency in English; are transparent in your communication and value open and honest dialogues– talking to the WHY

• Thrive in finding the right and compliant solution for all

• Stay calm in challenging situations to facilitate the right decisions are made

• Think outside the box and challenge the status quo

EducationThe right mindset, strong deliverables and willingness to integrate is key. Educational background comes second but could be within the following areas (though not prerequisite), Bachelor or Master of Science in natural science, e.g. Pharmacy, Biotechnology, Biology, Engineering or similar.We hope you are

• Self-starting and approach tasks and colleagues with openness, flexibility and great energy.
• Analytical and understand the importance of involving stakeholders in your daily work.
• Thriving in empowering and developing your employees.

Your New Team & DepartmentCurrently the team consists of 8 persons and is part of a QA department also overseeing the quality of Raw Materials & Supply Chain – and further part of a larger QA organization which provides quality support to production of batches in drug substance manufacturing, filling of drug product and Assembly, Label and Pack.The QA team is a dynamic team that has close collaboration with multiple internal and global stakeholders and QA colleagues.The team supports timely QA review and approval of change controls, deviations, out of specification results, SOP updates, instrument qualification records and method transfer documentation.Furthermore, the team engages proactively with the QC organization to enhance compliance and secure quality oversight support in general.In addition, FDB values the manager network across all functions, and you will have a closer network with your peers across the QA operations department. In this network, you will be able to share knowledge and experiences with your peers and exchange ideas about best practices as well as share your own learnings and experiences with the manager network.The work environment is international and informal. We keep a high pace and focus on a vital life balance while having fun. We put a strong emphasis on psychological safety through trust and empowerment within our teams and hope that this is something that speaks to you as well.Your applicationHas this sparked your interest? Then please upload your CV and cover letter as soon as possible as we conduct interviews on an ongoing basis and will take down the advert when we have found the right candidate.In case you have any questions, please do not hesitate to reach out to Manager in Quality Assurance Trine Outzen onFUJIFILM Diosynth Biotechnologies is a global leader in biologics contract development and manufacturing Organization (CDMO), partnering with innovative biotech and biopharma companies to transform healthcare. With locations in Denmark, the UK, and the USA, we support every stage of our customers’ product lifecycle, from breakthrough cures to life-saving vaccines.Our success starts with our people—their passion drives progress, innovation, and impact. Join a diverse, inclusive workplace that values collaboration, fosters growth, and empowers future generations. Together, we’re enriching communities, protecting the environment, and reimagining healthcare’s potential.Shape the future with us—your drive meets boundless opportunity hereFUJIFILM Diosynth Biotechnologies Denmark (FDBD) is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, 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.

Oczekiwane wynagrodzenie

Lokalizacja

Hillerød, Hovedstaden

Data pracy

Thu, 10 Apr 2025 06:58:07 GMT

Aby pomóc nam śledzić nasze działania rekrutacyjne, prosimy wskazać w swoim e-mailu/liście motywacyjnym, gdzie (jobsineu.net) widziałeś tę ofertę pracy.