Associate Director QA Drug Substance

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

Introduction

Are you an experienced QA leader with a strong background in Drug Substance manufacturing? Do you thrive in a fast-paced environment where quality, collaboration, and continuous improvement are key to success? Then you may be our new Associate Director QA DS at FUJIFILM Biotechnologies in Hillerød.

About the role

As Associate Director QA DS, you will lead one of our QA Drug Substance value stream teams and play a key role in ensuring compliance, quality oversight, and operational excellence across our manufacturing operations. Working closely with Manufacturing, Process Sciences, and other key stakeholders, you will support the continued growth of our business while ensuring that quality standards are maintained and continuously improved.

Your responsibilities

• Leading and developing a team of QA professionals and managers
• Providing QA oversight and support for Drug Substance manufacturing operations
• Driving compliance with cGMP requirements and internal quality standards
• Supporting internal and external audits and regulatory inspections, ensuring timely and sustainable follow-up on observations
• Driving performance management through KPIs, quality metrics, trend analysis, and management review input
• Leading cross-functional problem-solving initiatives to improve process robustness, reduce recurrence, and strengthen right-first-time performance
• Building strong relationships with customers and acting as a senior QA representative in a CDMO environment
• Contributing to continuous improvement initiatives and helping shape the future direction of the QA organization

Qualifications and experience

• 10+ years of experience within pharmaceutical or biotechnology Quality Assurance, including substantial Drug Substance manufacturing experience
• Experience from a CDMO environment is highly preferred
• 5+ years of leadership experience with a proven track record of building, developing, and leading teams
• Strong knowledge of cGMP and quality systems, including deviations, CAPA, change control, risk management, validation, training, and batch disposition support
• Experience driving compliance, operational excellence, and continuous improvements across complex stakeholder landscapes
• Strong communication and stakeholder management skills, with confidence engaging senior leaders, customers, and regulatory inspectors
• Strong analytical and decision-making capabilities
• A degree within Life Sciences, Pharmacy, Engineering, or a related field
• Fluency in English, both written and spoken. Danish is considered an advantage

About the team

You will lead one of four QA Drug Substance teams supporting our manufacturing organization in Hillerød. The team works closely with Manufacturing and Process Sciences and plays an important role in ensuring the successful delivery of products to our customers. You will become part of a dynamic and international work environment where collaboration, accountability, and continuous improvement are highly valued.

Working at FUJIFILM Biotechnologies

We offer a competitive compensation package in a site/company growing rapidly, with many opportunities for individual growth. We also offer access to fitness and an attractive canteen.

• competitive compensation package
• access to fitness
• attractive canteen

FUJIFILM 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