Associate Director, QA DS – Drug Substance Quality Lead

FUJIFILM Biotechnologies; Hillerød; On-site; DKK 1,345,000 - 1,868,000; Full time

Benefits offered by this job

Fitness facilities

Canteen

Job summary

FUJIFILM Biotechnologies in Hillerød is seeking an Associate Director QA DS to lead one of our QA Drug Substance teams. You will ensure compliance, quality oversight, and operational excellence across manufacturing operations, working closely with Manufacturing and Process Sciences.

You will guide regulatory readiness, audits, and continuous improvement initiatives while engaging senior leaders and customers in a dynamic CDMO environment. Fluency in English is required; Danish is an advantage.

Qualifications

• 10+ years in pharmaceutical or biotechnology QA.
• Drug Substance manufacturing experience required.
• CDMO experience preferred.
• 5+ years in leadership building and leading teams.

Responsibilities

• Lead QA Drug Substance value stream teams and ensure compliance and quality oversight.
• Drive cGMP compliance and internal quality systems across operations.
• Support audits and regulatory inspections with timely follow-up on observations.
• Manage KPIs, quality metrics, trend analysis, and management review input.
• Lead cross-functional problem solving to improve process robustness and right-first-time.

Skills

QA Leadership

cGMP Knowledge

Quality Systems

Stakeholder Management

Data Analysis

Problem Solving

Communication

Audits & Regulatory Inspections

Continuous Improvement

Education

Life Sciences / Pharmacy / Engineering degree

Job description

FUJIFILM Biotechnologies in Hillerød is seeking an Associate Director QA DS to lead one of our QA Drug Substance teams. You will ensure compliance, quality oversight, and operational excellence across manufacturing operations, working closely with Manufacturing and Process Sciences.

You will guide regulatory readiness, audits, and continuous improvement initiatives while engaging senior leaders and customers in a dynamic CDMO environment. Fluency in English is required; Danish is an advantage.