Senior QA for QC Specialist - Method Transfer Expert

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

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