QA DS Associate Director - Drug Substance Leadership

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

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.