Associate Director for Compliance Support - Drug Substance Manufacturing

Join our team as an Associate Director, spearheading innovation and excellence in our Compliance Support area within Drug Substance Manufacturing. We are dedicated to streamlining processes, improving efficiency, and ensuring high-standard compliance that resonates across our sites.

Position Overview
As the Associate Director for Compliance Support, you will play a pivotal role in managing and optimizing the deviation flow, ensuring transitions from initiation to closure within a newly established timeframe of 30 days, down from the previous benchmark of 45 days. This role involves overseeing a systematic approach to deviation management, one that prioritizes root cause analysis and the establishment of robust Corrective and Preventive Actions (CAPAs) to prevent recurrence.

Key Responsibilities

• Manage two dedicated teams:
  • Front-office Team: Perform initial impact assessments, conduct interviews, and gather necessary data.
  • Back-office Team: Focused on in-depth investigations, CAPA definitions, and customer interactions.
    
• Oversee the entire deviation process, ensuring efficiency in a 30-day flow.
• Lead efforts in identifying root causes and implementing effective CAPAs.
• Monitor trends and take proactive measures to prevent future occurrences both domestically and across our international sites.
• Facilitate informal leadership in managing a critical business flow under strict time constraints, requiring collaboration across diverse company domains such as Process Science, Automation, Engineering, Facilities, QC, Quality, and Digital Technologies.
• Engage with customers actively during the deviation flow, maintaining open communication and providing strategic oversight.
• Prepare and participate in audits and inspections, ensuring compliance with both internal standards and regulatory bodies.
  

Qualifications

• Proven leadership experience in compliance management within pharmaceutical manufacturing.
• Strong analytical skills, particularly in root cause analysis and CAPA development.
• Exceptional interpersonal and communication skills, with the ability to engage effectively with stakeholders at all levels.
• Experience in navigating cross-functional collaborations within a complex organizational structure.
• Ability to manage multiple priorities in a high-pressure environment while maintaining a focus on process improvement and customer satisfaction.

About Drug Substance Manufacturing Support
We are an organization of app. 100 employees supporting our drug substance manufacturing organization in various areas such as campaign readiness, projects and changes, preparing and reviewing records, establishing and updating work instructions, arranging training activities as well as handling deviations and CAPAs.

We embrace change and strive for excellence in a dynamic environment as a CDMO serving multiple customers. In this our people fundamentals are key in striving for robust processes and continuous improvements.

Why Join Us?
This role offers a unique opportunity to lead two dynamic teams in a fast-paced and environment where your decisions directly impact our organizational success and customer satisfaction. Become a part of a company that values expertise, leadership, 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 will take candidates into the recruitment process continuously, so do not hesitate to apply. This position will remain open until a suitable candidate has been found.

If you have any questions about this role, please reach out to Karin Toftegaard, Director, Manufacturing, at phone: 45 2215 6879.

Curious to know more about the company? Then check out our home page: https://fujifilmdiosynth.com/cdmo-facilities/denmark/

Working at FUJIFILM Diosynth 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 Diosynth 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 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.

Location: FDBD Hillerod