Lead, Compliance Investigations - GMP & LEAN

FLBD FUJIFILM Life Sciences Biotechnologies Denmark ApS; Hillerød; On-site; DKK 850,000 - 1,150,000; Full time

Benefits offered by this job

Fitness facilities

Canteen

Job summary

FUJIFILM Biotechnologies Denmark in Hillerød, Denmark, seeks an Associate Manager to lead the Compliance Support Team for a single end-to-end API line (cell culture through purification). You will drive deviation handling, root cause analysis, CAPAs, and audit readiness while collaborating with Manufacturing, QA, MSAT, Engineering and Planning.

You will manage 6–12 Investigators, establish priorities, ensure timely investigations, and maintain cGMP compliance with a safety-first culture.

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; experience with LEAN, flow optimization, and visual planning is a strong advantage.
• Solid knowledge of cGMP, data integrity, and documentation standards within pharma/biotech.
• Experience interfacing with API production and both cell culture and purification operations is a strong plus.

Responsibilities

• Lead, coach, and develop a high-performing team of Investigators.
• Set direction and priorities, manage workload, and ensure motivation and accountability.
• Own daily/weekly planning, triage, and queue management to meet end-to-end lead time targets.
• Ensure high-quality investigations, robust root cause analysis, effective CAPAs, and strong deviation documentation across USP and DSP.
• Drive standard work, visual management, and performance metrics (cycle time, aging, RFT).
• Optimize handovers and escalation paths with Manufacturing and QA to secure flow across unit operations.
• Build audit readiness through housekeeping, data integrity, and compliance rigor.
• Promote cross-training and capability building to enhance flexibility across USP/DSP.
• Challenge status quo and implement LEAN/continuous improvements end-to-end.
• Communicate changes, risks, and decisions clearly; follow through and close actions.
• Deliver on time per internal/customer agreements while maintaining cGMP compliance and a safety-first culture.

Skills

People management

GMP

Deviation management

Root cause analysis

CAPA

LEAN

Data integrity

cGMP

Cross-functional collaboration

English communication

Danish language

Job description

FUJIFILM Biotechnologies Denmark in Hillerød, Denmark, seeks an Associate Manager to lead the Compliance Support Team for a single end-to-end API line (cell culture through purification). You will drive deviation handling, root cause analysis, CAPAs, and audit readiness while collaborating with Manufacturing, QA, MSAT, Engineering and Planning.

You will manage 6–12 Investigators, establish priorities, ensure timely investigations, and maintain cGMP compliance with a safety-first culture.