Senior QA DS Leader – Drug Substance, cGMP Expert

FUJIFILM Biotechnologies; Hillerød; Sur place; DKK 1 000 000 - 1 600 000; Plein temps

Avantages offerts par ce poste

Fitness facilities

Canteen

Competitive compensation package

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

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

Formation

Life Sciences / Pharmacy / Engineering degree

Description du poste

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