GMP Compliance Lead: Validation & Quality Systems

Bavarian Nordic; Kvistgård; On-site; DKK 739,000 - 903,000; Full time

Job summary

Bavarian Nordic in Denmark seeks an experienced Manager, Compliance to lead a diverse team responsible for critical compliance and validation activities across site Engineering. The role requires driving GMP adherence and building a culture of quality and continuous improvement.

You will oversee Change Control, Deviations, CAPAs, risk assessments, and regulatory audits while partnering with Production, QA, Regulatory Affairs, and other stakeholders to deliver high-quality outcomes.

Qualifications

• Proven leadership experience in a GMP-regulated environment.
• Solid understanding of compliance, validation, and quality management systems.
• Experience with Change Control, Deviations, CAPAs, risk management, and continuous improvement activities.
• Experience of internal and external Regulatory audits is an important pre-requisite.
• Strong stakeholder management and communication skills.
• Ability to lead teams with diverse educational and professional backgrounds.

Responsibilities

• Lead, coach, and develop a team of specialists with diverse backgrounds.
• Ensure timely execution of compliance activities across the site.
• Support the planning, execution, and lifecycle management of validation activities.
• Drive compliance initiatives and ensure adherence to GMP requirements and internal standards.
• Oversee Change Control, Deviations, CAPAs, risk assessments, and other quality system processes.
• Collaborate with Production, Engineering, QA, Regulatory Affairs, and stakeholders.

Skills

Leadership

Stakeholder management

Quality management systems

GMP knowledge

Regulatory affairs liaison

Education

Engineering

Life Sciences

Pharmacy

Biotechnology

Quality Management

Job description

Bavarian Nordic in Denmark seeks an experienced Manager, Compliance to lead a diverse team responsible for critical compliance and validation activities across site Engineering. The role requires driving GMP adherence and building a culture of quality and continuous improvement.

You will oversee Change Control, Deviations, CAPAs, risk assessments, and regulatory audits while partnering with Production, QA, Regulatory Affairs, and other stakeholders to deliver high-quality outcomes.