Head of Validation

Job title:

Head of Validation

Company

Fujifilm

Job description

Are you a passionate leader who excel at building trust through your leadership style? Can you leverage the quality agenda by communicating validation activities in an understandable manner across the organization? Do you thrive navigating complex landscapes and can you set the strategic course to fit the growth journey ahead of us? If so, we have an exciting opportunity for you, to join our team and make an impact as Head of Validation.Ensuring world class quality and validation operationsWe are looking for a quality-minded and strategic-thinking Head of Validation that can set direction for our Validation department. In this role, you will be responsible for the qualified and validated state of our facilities, utilities, and equipment at our manufacturing site in Hillerød. You will work closely with senior management and the validation teams to set the standard for daily operations in our current manufacturing facility, while playing a key role in our expansion projects ensuring world-class quality and validation solutions.As the Head of Validation, you will be responsible for overseeing a department of approx. 32 knowledgeable and skilled colleagues who are always eager to learn and improve, with the support of 2 Managers. The responsibility in the department covers everything from qualification of new equipment, chamber validation, cleaning validation, participation in projects/changes and ensuring alignment between the ongoing operations supporting existing drug substance manufacturing and the expansion projects on site.You will focus on fostering a strong and healthy culture where we prioritize people and have a “People First” mindset. Our aim is to grow the organization in a healthy and efficient manner, consistently delivering the right quality on time to support the significant expansion of our site.Additionally, you will:

• Coach and develop leaders.
• Ensure efficient operation and collaboration between the two teams.
• Facilitate smooth cross-functional collaboration with stakeholders across the entire value chain.
• Oversee the development and improvement of validation processes and standards.
• Promote and support systematic problem-solving and continuous improvement.

Experienced leader with a people first mindsetAs the Head of Validation, you will lead with humility and respect for the individuals. You will listen curiously to colleagues to learn and understand the landscape in which we operate.
Additionally, you bring:

• Over 5 years of leadership experience within the pharmaceutical industry.
• Strong strategic and analytical skills.
• Excellent communication skills with the ability to set a clear direction to all levels.
• A solid understanding of and experience with complex processes and change management.
• The ability to be a role model who practices visible leadership.
• Talent for building trust and psychological safety at all organizational levels.
• Competencies to promote a culture trust, ownership, and empowerment.
• Fluent spoken and written English skills.

As a leader, you approach your role with openness and positive energy, bringing people together and elevating those around you through your leadership style. You are a natural self-starter with a systematic and dynamic approach to work. If you see yourself as a high-performing team player who is ambitious both for yourself and the company, then you might be the candidate we are looking for!Join an organization where trust and ownership drive success
As our new Head of Validation, you will report to the Sr. Director of Process Technologies and become part of a large, dynamic organization consisting of approximately 120 dedicated professionals. Our team includes five departments: Automation, Process Engineering, Validation, Engineering Science, and CAD Services.Our teams ensure smooth daily operations by providing engineering technical leadership and support for all cell culture, purification, and pharmaceutical processing equipment. We value collaboration and knowledge sharing, taking pride in delivering robust services and solutions to our stakeholders. We lead through trust, we embrace ownership, and excel at identifying and highlighting challenges and improvement opportunities, creating significant value in our journey towards operational excellence.Who are weFUJIFILM Diosynth Biotechnologies is a company on a journey to become the leading and most trusted global Contract Development and Manufacturing Organization (CDMO). In addition to these goals, our ambition is to become the largest end-to-end cell culture facility in Europe.
Our manufacturing site in Hillerød, brings together a complete range of expertise, capabilities, and technologies to manufacture advanced biologics. Our large-scale drug substance manufacturing facility today has a capacity of 6 x 20,000 liters bioreactors to manufacture biopharmaceuticals for late phase and commercial use. Our ongoing expansions in Hillerød will bring us to a total of 20 x 20,000 liters bioreactors within the coming years.As we continue to increase and expand our facilities, we are looking for people who share our passion, drive, and energy – what we call Genki. Currently we are +1800 employees at the Hillerød site and representing more than 70 nationalities.Interested?
If you are ready to advance your career and shape the future of our Validation department, then please send us your application and CV. We review candidates on an ongoing basis, so do not hesitate to apply. This position will remain open until a suitable candidate has been found.Curious to know more? Then check out our website:About FUJIFILM Diosynth BiotechnologiesWe are 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.Our Manufacturing site in Hillerød, Denmark, brings together a complete range of expertise, capabilities and technologies to manufacture advanced biologics. As we continue to enhance and expand our capabilities, we are looking for people who share our passion, drive, and energy – what we call Genki – to join our team.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, 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.

Expected salary

Location

Hillerød, Hovedstaden

Job date

Wed, 29 Jan 2025 07:50:21 GMT

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