Director of Quality (QA/QC, Life Sciences, Remote)

Job summary

The Director of Quality (QA/QC) is responsible for overseeing quality assurance and quality control within a regulated life sciences environment. This role involves leading the QA and QC teams, implementing a new electronic Quality Management System (eQMS), and ensuring compliance with regulatory standards. The position requires strategic leadership and hands-on involvement in quality processes, with a focus on continuous improvement and effective communication with stakeholders.

Qualifications

• Relevant academic background, such as M.Sc. in Pharmacy, Chemistry, Chemical Engineering, Biotechnology, or similar
• Significant experience in QA and/or QC leadership roles within a regulated life science setting, preferably in a CDMO, pharmaceutical, or medical device manufacturing environment
• Strong knowledge of GMP, ISO 13485, ICH, and other relevant standards
• Proven experience in hosting audits and navigating certification processes
• Hands-on experience with eQMS implementation, preferably with CANEA
• Skilled in negotiating and managing Quality Agreements with customers and suppliers
• Strong leadership and communication skills, capable of engaging with various stakeholders
• Fluent in English, with knowledge of Danish considered an advantage

Responsibilities

• Oversee QA and QC operations, ensuring compliance and reliability in customer supply
• Lead and develop the QA and QC teams, establishing clear priorities and fostering competence development
• Drive the implementation of the eQMS CANEA, including training and process adoption
• Manage customer quality interfaces and maintain Quality Agreements
• Prepare for and host customer and authority audits, addressing observations and corrective actions
• Plan and execute GMP certification processes, including gap analysis and remediation
• Ensure alignment of the quality system with evolving regulatory expectations
• 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 the management team

Skills

• Strong leadership and strategic thinking abilities
• Excellent communication and negotiation skills
• Proficient in quality management systems and regulatory compliance
• Ability to drive cultural change towards quality and accountability

Education

• M.Sc. in a relevant field such as Pharmacy, Chemistry, or Biotechnology

Tools

• Experience with electronic Quality Management Systems (eQMS), particularly CANEA