Associate Director QA Drug Substance

Fujifilm; Hillerød; On-site; DKK 1,000,000 - 1,500,000; Full time

Benefits offered by this job

Fitness facilities

Canteen

Competitive package

Job summary

FUJIFILM Biotechnologies in Hillerød, Denmark, seeks an Associate Director QA DS to lead one of our QA Drug Substance value stream teams, ensuring compliance, quality oversight, and operational excellence across manufacturing operations.

You will drive cGMP, manage audits, and lead cross-functional initiatives to improve right-first-time performance while collaborating with senior stakeholders in a global CDMO environment.

Qualifications

• Ten plus years in pharmaceutical/biotech QA with Drug Substance manufacturing.
• Five plus years in leadership building and guiding teams.
• Strong knowledge of cGMP, deviations, CAPA, change control, risk management, validation, training, batch disposition.
• Experience with audits, regulatory inspections, and follow-up actions.
• Excellent communication with senior leaders, customers, and regulators.
• Fluency in English; Danish is an advantage.

Responsibilities

• Lead and develop the QA DS value stream team.
• Provide QA oversight for Drug Substance manufacturing operations.
• Drive cGMP compliance and internal quality standards.
• Support audits and regulatory inspections with timely follow-up actions.
• Lead cross-functional problem-solving to improve process robustness.
• Build strong relationships with customers as senior QA representative in a CDMO environment.
• Contribute to continuous improvement initiatives and shape QA direction.

Skills

QA Leadership

cGMP Compliance

Drug Substance Manufacturing

Quality Systems

Regulatory Inspections

Stakeholder Management

CAPA Management

Data Analytics

English Fluency

Leadership Development

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 roleAs 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 managersProviding QA oversight and support for Drug Substance manufacturing operationsDriving compliance with cGMP requirements and internal quality standardsSupporting internal and external audits and regulatory inspections, ensuring timely and sustainable follow-up on observationsDriving performance management through KPIs, quality metrics, trend analysis, and management review inputLeading cross-functional problem-solving initiatives to improve process robustness, reduce recurrence, and strengthen right-first-time performanceBuilding strong relationships with customers and acting as a senior QA representative in a CDMO environmentContributing to continuous improvement initiatives and helping shape the future direction of the QA organizationQualifications and experienceTo succeed in this role, we imagine that you bring:10+ years of experience within pharmaceutical or biotechnology Quality Assurance, including substantial Drug Substance manufacturing experienceExperience from a CDMO environment is highly preferred5+ years of leadership experience with a proven track record of building, developing, and leading teamsStrong knowledge of cGMP and quality systems, including deviations, CAPA, change control, risk management, validation, training, and batch disposition supportExperience driving compliance, operational excellence, and continuous improvements across complex stakeholder landscapesStrong communication and stakeholder management skills, with confidence engaging senior leaders, customers, and regulatory inspectorsStrong analytical and decision-making capabilitiesA degree within Life Sciences, Pharmacy, Engineering, or a related fieldFluency in English, both written and spoken. Danish is considered an advantageAbout the teamYou 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.ApplicationWe are reviewing applications on an ongoing basis and encourage you to apply as soon as possible.Working at FUJIFILM BiotechnologiesWe 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.To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via email, the internet, or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.