Audit and Inspections Manager for Global Quality

We're seeking an Audit & Inspection Manager for our global Quality department to spearhead the development of cutting-edge tools and strategies that redefine inspection and audit management. Join us, and be the catalyst for transformative change across our organization.

FUJIFILM Diosynth Biotechnologies is a world leading Contract Development Manufacturing Organization (CDMO) serving customers in the pharmaceutical industry – from pre-clinical investigations to commercial GMP production.

The QA Audit & Inspection Manager is responsible for the creation of tools (software), inspection playbooks and interpretation of data relevant to inspection and audit management. In this pivotal role you will assist the Sr. Dir. of Inspection Management to train all sites in the organization's network in aligned process to conduct inspections. You will participate in regulatory inspections and internal audits at all sites to ensure learnings are captured and shared across the network. You will continuously collect and share learnings to ensure systematic improvements are shared across the network.

Principal Tasks:

• Support developing and Implementing a standardized process (Inspection Playbook) including a material repository for sites maintaining “Inspection Ready Status” for preparing, executing and responding to regulatory inspections across all FDB sites in collaboration with all site QA Inspection Leads.
• Assist the site(s) in conducting inspections by providing project management assistance during preparation and conducting of inspections.
• Lead and support in analyzing quality KPI data, e.g. audit and inspection data to detect patterns and define and implement local and global preventative actions.
• Facilitate meetings, workshops and training session including generating of presentations and communications of key milestone deliverables across the network.
• Support the design and management of a multi-year Global Internal Audit Plan, leveraging Global data to identify high-risk and cross-site focus areas.
• Support the development and implementation of a multi-year mock-audit plan using defined risk-based criteria to assess inspection readiness. Co-ordinate both planned and unannounced mock-audits to proactively identify gaps, drive improvements and ensure alignment with regulatory expectations.

This is a hybrid role based at our site in Hillerød in Denmark, reporting to the Sr Director Global QA Audits & Inspections. The role involves traveling both domestically and internationally for 30 days a year. Flexibility and adaptability to travel schedules are essential components of this position.

Qualifications:

• Bachelor's or Master's degree in a related discipline
• 3 years as an experienced project manager
• Basic knowledge of inspection management or other pharmaceutical projects
• Proven experience with developing training and delivering training to inspection teams
• Proven experience in setting up logistics and software tools to enable inspection support
• Advanced knowledge of Smartsheet, OneNote, and Microsoft programs is preferred

Knowledge, Skills and Abilities

• Collaborative mindset - willingness to work with global peers and cross-functional teams to drive alignment and achieve company goals
• Strong planning and organizational skills – Ability to structure and manage multiple initiatives, ensuring timely execution and effective prioritization.
• Effective communication skills – Able to clearly convey complex information through presentations, reports, and stakeholder’s discussions.
• Training and facilitation skills – comfortable leading workshops, meetings, and training sessions to drive alignment and engagement
• Excellent oral and written communications skills and fluency in English

Application:

Please upload your CV and cover letter as soon as possible as we screen applications on a continuous basis. We will remove the job advertisement when the right candidate has been identified.

As part of any recruitment process, FUJIFILM Diosynth Biotechnologies collects and processes personal data relating to job applicants. The organisation is committed to being transparent about how it collects and uses that data and to meeting its data protection obligations and may share this as part of the global recruitment process with hiring managers in Europe and the United States.

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.

The culture at FUJIFILM Denmark (FDBD) is key if you ask our employees and besides a competitive salary and bonus package, we offer health insurance, massage and physiotherapy, health check, fitness center, possibility to work from home and most recently we invested in a mobile barista coffee van. FDBD also has a canteen arrangement incl. Friday brunch and monthly afternoon cake, just as we have a “bell ringing” tradition when reaching important milestones.

FUJIFILM Diosynth Biotechnologies Denmark (FDBD) is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, 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