Associate Director QA Drug Substance

FUJIFILM Biotechnologies; Hillerød; On-site; DKK 1,000,000 - 1,600,000; Full time

Benefits offered by this job

Fitness facilities

Canteen

Competitive compensation package

Job summary

FUJIFILM Biotechnologies in Hillerød seeks an Associate Director QA DS to lead a Drug Substance QA team and ensure compliance, quality oversight, and operational excellence in manufacturing. You will collaborate with Manufacturing and Process Sciences, drive continuous improvement, and act as a senior QA representative in a CDMO environment, shaping the QA organization’s future direction.

The role demands strong leadership, strategic thinking, and a proven track record in cGMP, audits, and

Qualifications

• 10+ years of experience in pharmaceutical/biotech QA with Drug Substance manufacturing.
• Leadership experience for 5+ years building and guiding teams.
• Strong knowledge of cGMP, deviations, CAPA, change control, risk management, validation, and batch disposition.

Responsibilities

• Lead and develop a team of QA professionals and managers.
• Provide QA oversight for Drug Substance manufacturing operations.
• Drive compliance with cGMP and internal quality standards.
• Support internal/external audits and regulatory inspections with timely follow-up.
• Drive performance metrics, trends, and management review input.
• Lead cross-functional problem-solving to improve process robustness and right-first-time performance.
• Build relationships with customers and represent QA in a CDMO environment.
• Contribute to continuous improvement and future QA strategy.

Skills

QA leadership

Drug Substance manufacturing

CDMO experience

cGMP & quality systems

Deviations & CAPA

Change control

Risk management

Process improvement

Regulatory audits

Stakeholder management

English fluency

Danish language advantage

Education

Life Sciences / Pharmacy / Engineering degree

Job description

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 will include:

• 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

To succeed in this role, we imagine that you bring:

• 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.

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. We work across the entire lifecycle of our customers' products - enabling success throughout. Every cure, vaccine, biologic, and advancement we contribute to starts with our people and our passion. We fuel one another's passion, help accelerate progress, expand capabilities, strengthen innovation, and improve processes to improve lives.

Our Manufacturing site in Hillerød, Denmark, brings together a complete range of expertise, capabilities, and technologies to manufacture advanced biologics. As we continue to enhance and expand our capabilities, we are looking for people who share our passion, drive, and energy - what we call Genki to join our team.

We offer the chance to be part of a global workplace where passion, drive, and commitment are met with opportunities for professional and personal development. Deeply committed to diversity and inclusion, we ensure that everyone - no matter their background or gender - has an opportunity to develop. We take pride in enriching our communities, caring for our environment, and cultivating a world of opportunity for future generations.

We aim to foster a collaborative, innovative, and rewarding environment, where diverse perspectives and people come together united by a common purpose and shared values. We pursue our fullest potential as individual contributors and team members. We strive to be the employer of choice and offer a competitive compensation and benefit package.

FUJIFILM Biotechnologies Denmark is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation, gender identity, or any other protected class.