Join our team as an Associate Manager, driving innovation and excellence in our Compliance Support division within Drug Substance Manufacturing. We are committed to streamlining processes, enhancing efficiency, and ensuring compliance of the highest standards across our sites.

This role presents a unique opportunity to lead a dynamic team in a fast-paced environment where your decisions significantly impact organizational success and customer satisfaction. Become part of a company that values expertise, leadership, and innovation.

Position Overview
As the Associate Manager for Compliance Support, you will be instrumental in guiding our team toward achieving exceptional efficiency, overseeing the deviation process from initiation to closure within a newly established timeframe of 30 days rather than the previous 45 days.
You will supervise the process, offering strategic direction to team members in meeting deadlines while maintaining superior quality standards.
Your leadership will focus on fostering a systematic approach to deviation management, prioritizing root cause analysis and the formation of robust Corrective and Preventive Actions (CAPAs) to prevent recurrence.

Key Responsibilities

• Inspire and lead informal leadership within the team focused on critical business flow.
• Cultivate the development of our multicultural team, both personally and professionally, with a strong emphasis on FUJIFILM People Fundamentals.
• Direct and energize a committed team by:
  • Support and sparring in impact assessments, interviews, and data collection.
  • Encouraging regular GEMBA walks for all team members.
  • Steering in-depth investigations, CAPA definitions, and customer interaction.
  • Managing the entire deviation process for optimum efficiency in a 30-day timeline.
  • Driving efforts to identify root causes and implement effective CAPAs.
• Navigate stakeholder management across company domains including Process Science, Automation, Engineering, Facilities, QC, Quality, and Digital Technologies.
• Cultivate active customer engagements throughout the deviation flow, ensuring open communication and strategic oversight.
• Prepare for and participate in audits and inspections, ensuring compliance with internal standards and regulatory requirements.

Qualifications

• Proven experience in people leadership within compliance management in pharmaceutical manufacturing.
• Strong analytical skills, proven GMP experience and expertise in root cause analysis and CAPA development.
• Ability to manage multiple priorities in a high-pressure environment and guide your team in navigating these priorities.
• Outstanding interpersonal and communication skills to effectively engage with employees and stakeholders.
• Experience in cross-functional collaborations within complex organizational structures.

About the Compliance Support Team
Our team consists of approximately 23 Compliance Engineers dedicated to supporting our drug substance manufacturing organization in managing incidents and deviations, integral to areas such as commercial release, campaign readiness, and project support.
We embrace change and strive for excellence in our dynamic CDMO environment, serving numerous customers.
Our People Fundamentals are central to our pursuit of robust processes and continuous improvement.

Application Process
Interested candidates are encouraged to apply through our career portal. Please submit your resume and a cover letter detailing your relevant experience and motivation for applying.
We continuously welcome applicants, so do not hesitate to apply.
This position will remain open until we find the ideal candidate.

If you have any questions regarding this role, please contact Lars Nislev, Ass. Director of Compliance Support, at phone: +45 2783 4435 - after 7th of July.

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.