Director of Quality (QA & QC)

Job summary

The Director of Quality (QA/QC) is responsible for overseeing quality at the organization, acting as the senior quality leader and a member of the management team. This role involves leading the QA and QC teams, implementing a new electronic Quality Management System (eQMS), and planning for GMP certification.

Qualifications

• Relevant academic background, such as M.Sc. in Pharmacy, Chemistry, Chemical Engineering, Biotechnology, or similar
• Solid experience in QA and/or QC leadership roles within a regulated life science environment, preferably in a CDMO, pharmaceutical, or medical device manufacturing
• Strong knowledge of GMP, ISO 13485, ICH, and relevant standards
• Proven experience with customer and authority audits and driving certification processes
• Hands-on experience with eQMS implementation; experience with CANEA is a plus
• Experience in negotiating and managing Quality Agreements
• Strong communication skills in English; knowledge of Danish is advantageous

Responsibilities

• Oversee QA and QC, ensuring compliance and reliability in supply
• Lead and develop the QA and QC teams through effective management
• Implement the eQMS CANEA, including training and process design
• Manage customer quality interfaces and maintain Quality Agreements
• Prepare for and host customer and authority audits
• Plan and execute GMP certification processes
• Ensure compliance with regulatory requirements and align quality systems with evolving standards
• Oversee batch release, deviations, change control, and internal audits
• Promote a culture of continuous improvement and data-driven decision-making
• Report on quality performance and risks to management

Skills

• Structured and pragmatic leadership style
• Ability to balance strategic direction with hands-on involvement
• Strong negotiation and management skills

Education

• M.Sc. or equivalent in a relevant field

Tools

• Experience with electronic Quality Management Systems (eQMS), specifically CANEA is advantageous