Senior QA for QC Specialist (Principal level)

FUJIFILM Biotechnologies; Hillerød; On-site; DKK 850,000 - 1,200,000; Full time

Benefits offered by this job

Competitive compensation package

Fitness facilities

Canteen facilities

Job summary

FUJIFILM Biotechnologies Denmark in Hillerød is seeking a Senior QA for QC Specialist to provide high‑impact quality oversight of QC activities in a growing biopharma site. You will review complex method transfer documents, define QA expectations, and guide risk-based decisions while partnering with QC and QA colleagues to strengthen data integrity, compliant documentation, and regulatory readiness.

The role emphasizes collaboration, technical excellence, and mentoring across teams without

Qualifications

• Collaborative mindset and ability to integrate into the team.
• Deep knowledge of GxP, quality systems, and analytical lifecycle.
• Strong communication and organizational skills.

Responsibilities

• Provide specialized QA support to QC, including QC-AD, with a focus on complex analytical methods and data integrity
• Review and approve method transfer documents; define QA expectations, acceptance criteria, and risk controls
• Review and approve QC-related documentation (e.g., method validation/verification, protocols/reports, specifications, stability, reference standards)
• Assess and approve changes and deviations, acting as SME for root cause analysis, impact assessment, and CAPA effectiveness
• Ensure procedures and methodologies are followed and that complete, compliant documentation is captured and reported
• Act as a quality partner by providing expert guidance, targeted training, and ad hoc support to stakeholders (no direct people management)
• Represent QA for QC on QC-related projects and analytical lifecycle initiatives (e.g., method performance monitoring, trending, control strategy)
• Contribute to local and future global alignment within QA for QC by authoring/revising QA positions, procedures, and best practices
• Maintain internal training levels and stay current on cGMPs and regulatory requirements, as well as global procedures, guidelines, policies, frameworks, and specifications
• Serve as a senior specialist and sparring partner to the QA for QC Manager on complex topics (e.g., tech transfer strategy, risk management, compliance remediation, inspection readiness)

Skills

Collaborative mindset

GxP knowledge

cGMP for biologics

Data integrity principles

Deviations & CAPA SME

15+ years QA experience

Education

Bachelor or Master in natural science

Job description

Join our QA for QC team at FUJIFILM Biotechnologies in Hillerød as a Senior QA for QC Specialist, supporting our QC laboratory in this newly created position. As our production site grows, QC expands, which requires increased quality oversight.

We are looking for the right Senior QA for QC Specialist who would like to be part of a positive, engaged, and supportive team.

Currently, the team consists of 13 people and is part of a larger QA organization that provides quality support to drug substance manufacturing, drug product filling, and Assembly, Label and Pack. QA for QC is a dynamic team with close collaboration across multiple internal stakeholders and QA colleagues.

As a Senior QA for QC Specialist with 15+ years of relevant experience, you will act as a high-impact subject matter expert providing deep quality oversight of QC activities. You will review and approve complex method technology transfer documentation, set robust QA rationales, drive risk-based decisions, and advise on deviations and changes. You will partner closely with QC and QC-AD to strengthen compliance, data integrity, and analytical lifecycle control—serving as a senior specialist and sparring partner to the QA for QC Manager on complex quality matters.

Primary Responsibilities

• Provide specialized QA support to QC, including QC-AD, with a focus on complex analytical methods and data integrity
• Review and approve method technology transfer documents; define QA expectations, acceptance criteria, and risk controls
• Review and approve QC-related documentation (e.g., method validation/verification, protocols/reports, specifications, stability, reference standards)
• Assess and approve changes and deviations, acting as SME for root cause analysis, impact assessment, and CAPA effectiveness
• Ensure procedures and methodologies are followed and that complete, compliant documentation is captured and reported
• Act as a quality partner by providing expert guidance, targeted training, and ad hoc support to stakeholders (no direct people management)
• Represent QA for QC on QC-related projects and analytical lifecycle initiatives (e.g., method performance monitoring, trending, control strategy)
• Contribute to local and future global alignment within QA for QC by authoring/revising QA positions, procedures, and best practices
• Maintain internal training levels and stay current on cGMPs and regulatory requirements, as well as global procedures, guidelines, policies, frameworks, and specifications
• Serve as a senior specialist and sparring partner to the QA for QC Manager on complex topics (e.g., tech transfer strategy, risk management, compliance remediation, inspection readiness)

Qualifications / Skills

• Collaborative mindset with a willingness to integrate into the team and organization
• Deep knowledge of GxP and quality systems; strong command of cGMP for biologics, analytical lifecycle, and data integrity principles
• Able to operate in a highly dynamic environment and thrive while “building the road as we go”
• Self-driven and proactive with excellent communication skills and strong organizational abilities
• 15+ years of relevant QC/QA experience including oversight of complex analytical methods and tech transfers
• Experience with deviations, changes, CAPA, and risk assessment as an SME
• Comfortable handling complex, cross-functional issues and providing clear, defensible QA rationales and decisions

Education

The right mindset, strong deliverables, and practical experience are key. Educational background comes second but could be within the following areas (though not a prerequisite):

Bachelor’s or Master’s degree in a natural science, e.g., Pharmacy, Biotechnology, Biology, Engineering, or similar.

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 identify or any other protected class.