Compliance Support Lead, Deviation & Quality Improvement

FujiFilm

Hillerød

On-site

DKK 800,000 - 1,000,000

Full time

7 days ago
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Benefits offered by this job

Fitness access
Canteen on site
Career growth opportunities

Job summary

FUJIFILM Biotechnologies Denmark is seeking an Associate Manager to lead a 6–12-person Investigators team focused on deviations across a single end-to-end API line (cell culture through purification). You will drive LEAN improvements, standard work, and audit readiness while mentoring staff and coordinating with Manufacturing, QA, MSAT, and Engineering.

Ideal candidates have proven GMP leadership experience, strong RCA and CAPA skills, and excellent stakeholder management in a fast-paced

Qualifications

  • Proven people-management experience in GMP manufacturing or quality/compliance roles.
  • Strong track record in deviation management, root cause analysis, CAPA, and risk assessment.
  • Operational excellence mindset; LEAN, flow optimization, and visual planning are advantageous.

Responsibilities

  • Lead, coach, and develop a team of Investigators (6–12) overseeing deviations for a single end-to-end API line.
  • Own daily/weekly planning, triage, and queue management to meet end-to-end lead time targets.
  • Ensure high-quality investigations with robust root cause analysis, CAPAs and deviation documentation.

Skills

People-management
Deviation management
Root cause analysis
CAPA
LEAN
Data integrity
cGMP knowledge
Planning
Stakeholder management
English communication

Job description

FUJIFILM Biotechnologies Denmark is seeking an Associate Manager to lead a 6–12-person Investigators team focused on deviations across a single end-to-end API line (cell culture through purification). You will drive LEAN improvements, standard work, and audit readiness while mentoring staff and coordinating with Manufacturing, QA, MSAT, and Engineering.

Ideal candidates have proven GMP leadership experience, strong RCA and CAPA skills, and excellent stakeholder management in a fast-paced

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