Associate Manager for our Compliance & Support Documentation team

Do you have flair for compliance, and can you handle many stakeholders? Are you looking for a position where you can take on responsibility and lead and set direction for a skilled team?

Then join our team as a manager in the Drug Substance Compliance & Support Documentation team, overseeing 7-10 associates to ensure GMP compliance and timely document release. Drive process improvements and foster team engagement while enhancing organizational value within a dynamic work environment.

About the position

In the Drug Substance Compliance & Support Documentation team, we provide procedural support to GMP manufacturing and ensure compliance and document release activities in a timely manner. We create and maintain the document package for Drug Substance Manufacturing (DSM) and perform procedural changes as well as assessing impact of events.

As a Manager in Documentation support team, you will oversee 7-10 associates responsible for the above-mentioned activities, ensuring compliance with GMP standards and customer requirements. As part of the Documentation Support leadership team, you will enhance workplace satisfaction and add organizational value.

Responsibilities

Ensure all deliveries are aligned with strong GMP standards and customer requirements.

Lead with emotional intelligence to foster a thriving and engaged team environment.

Drive process improvements and adopt LEAN methodologies.

Utilize Quality Systems knowledge for coaching and cross-functional improvements.

Facilitate that SME support is provided during audits and inspections.

Assist in interviewing, training, and developing team members, ensuring compliance with policies.

Implement effective decision-making and corrective actions on the floor.

Qualifications

Bachelor or Master in Engineering, in Science or equivalent.

Experience with cGMP and pharmaceutical manufacturing, preferably 5-8 years within the industry.

Preferably experience with Veeva QualityDocs

Strong emotional intelligence and leadership skills.

Proficiency in Quality Systems with a focus on continuous improvement.

Ability to work strategically at tactical and operational levels.

Fluency in English is required.

About the department

In the department Drug Substance Manufacturing (DSM) Support we are responsible for supporting manufacturing operations with project management and compliance of procedures and documentation. Manufacturing Support consist of approx. 100 employees.

On a personal level our internal department workday is open, friendly, humorous, and relaxed. We create our own workday, and an individual and optimal work-life balance is highly prioritized. We meet with each other in social events and have the possibility to work from home, all dependent on nature of tasks and program.

As an employee in DSM Support, you will be thoroughly trained, we will set new realistic goals so that you continue your development and so that we support Fujifilm’s production the best possible way.

Your application

Has this sparked your interest? Then we urge you to please upload your CV and cover letter as soon as possible as we screen applications on a continuous basis. We will take down the advert when the position has been filled.

If you have any questions related to the job, please reach out to Associate Director, Manufacturing Support, Charlotte Lendal at phone: +45 2228 6696.

Please note, that due to summer holidays, interviews can be conducted in week 28-29 (7-18 July 2025).

Working at FUJIFILM Biotechnologies

We offer a competitive compensation package in a site/company growing rapidly, with many opportunities for individual growth, we also offer access to fitness and an attractive canteen.

FUJIFILM Biotechnologies is 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 Biotechnologies Denmark 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.

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