Associate Director QA Drug Substance | CDMO Leader

FLBD FUJIFILM Life Sciences Biotechnologies Denmark ApS; Hillerød; On-site; DKK 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Competitive compensation package

Access to fitness facilities

Attractive canteen

Job summary

FUJIFILM Biotechnologies in Hillerød, Denmark is seeking an experienced Associate Director QA DS to lead the QA Drug Substance value stream. You will drive compliance, quality oversight and operational excellence across manufacturing, collaborating with Manufacturing, Process Sciences and other stakeholders to enable growth while maintaining high quality standards.

You will lead a cross-functional team of QA professionals, manage audits and inspections, and advance continuous improvement across

Qualifications

• 10+ years of experience in pharmaceutical/biotechnology QA, including Drug Substance manufacturing.
• CDMO experience is highly preferred.
• 5+ years of leadership experience with building, developing, and leading teams.
• Strong knowledge of cGMP and quality systems (deviations, CAPA, change control, risk management, validation, training, batch disposition).
• Experience driving compliance, operational excellence, and continuous improvements across complex stakeholder landscapes.
• Strong communication and stakeholder management, with senior leaders, customers, and regulatory inspectors.
• Fluency in English; Danish is an advantage.

Responsibilities

• Lead and develop a team of QA professionals and managers.
• Provide QA oversight and support for Drug Substance manufacturing operations.
• Drive cGMP compliance and internal quality standards.
• Support internal and external audits and regulatory inspections with timely follow-up.
• Drive performance management via KPIs, quality metrics, trend analysis, and management review input.
• Lead cross-functional problem-solving to improve process robustness and right-first-time performance.
• Build relationships with customers and act as a senior QA representative in a CDMO environment.
• Contribute to continuous improvement initiatives and shape the QA organization’s future direction.

Skills

Leadership

Quality Assurance

Stakeholder management

Analytical thinking

Education

Life Sciences degree

Job description

FUJIFILM Biotechnologies in Hillerød, Denmark is seeking an experienced Associate Director QA DS to lead the QA Drug Substance value stream. You will drive compliance, quality oversight and operational excellence across manufacturing, collaborating with Manufacturing, Process Sciences and other stakeholders to enable growth while maintaining high quality standards.

You will lead a cross-functional team of QA professionals, manage audits and inspections, and advance continuous improvement across