Product Quality Lead (Pharmaceutical, Copenhagen)

Job summary

The role of Product Quality Lead involves overseeing quality for small molecule development programs, ensuring compliance with health authority expectations while supporting cross-functional teams through the development process. This position requires a blend of technical expertise and a risk-based approach to quality management.

Qualifications

• Degree in chemistry, biochemistry, or related pharmaceutical sciences (advanced degree preferred)
• 8–12+ years of experience in a regulated environment, with a focus on quality, development, manufacturing, or regulatory functions
• Experience in small molecule development, particularly in quality, analytical development, process development, or regulatory
• Strong understanding of cGMP and global health authority requirements
• Experience in cross-functional team collaboration and quality-related decision-making
• Familiarity with external partners such as CMOs is advantageous
• Proficient in data analysis and digital tools, with an interest in AI applications in quality
• Excellent communication skills and ability to work across diverse functions and cultures

Responsibilities

• Serve as the primary quality contact for assigned projects, engaging QA experts as necessary
• Conduct science- and risk-based evaluations of complex quality data
• Develop patient-focused strategies that balance quality, compliance, and business needs
• Identify and mitigate quality and health authority risks early in the development process
• Ensure alignment of development documentation with health authority standards
• Facilitate the transition of products from clinical development to commercial manufacturing
• Collaborate with internal stakeholders and external CMOs to align on quality expectations
• Utilize data and digital tools to enhance quality oversight and decision-making

Skills

• Strong analytical and problem-solving skills
• Ability to navigate complex regulatory environments
• Proficient in using digital tools and data analytics
• Strong interpersonal skills for effective collaboration

Education

• Degree in chemistry, biochemistry, or related field; advanced degree preferred

Tools

• Familiarity with digital tools and AI capabilities in a quality context