Senior Process and Compliance Manager

Freelio; Denmark; On-site; DKK 700,000 - 900,000; Full time

Job summary

Zealand Pharma A/S is seeking a regulatory-focused professional to lead inspection readiness for clinical trials and provide GCP advice across teams. You will develop and manage SOPs, checklists, and guides while supporting regulatory inspections and audits.

The ideal candidate brings a Life Sciences degree with biotech/pharma experience, deep ICH-GCP knowledge, and strong analytical and cross-functional collaboration skills. On-site role in Denmark with Zealand Pharma’s development portfolio.

Qualifications

• Bachelor’s degree in Life Sciences or related field; advanced degree preferred.
• Solid experience in biotech/pharma with clinical trial processes and compliance.
• Deep knowledge of ICH-GCP, FDA, and EMA requirements.
• Experience with clinical trial record management and regulatory submissions.

Responsibilities

• Lead Clinical Trial inspection readiness activities and support during regulatory inspections and audits.
• Develop, implement, and manage inspection readiness SOPs, guides, and checklists.
• Provide GCP advice and assist teams in responding to observations from inspections and audits.
• Enhance and maintain regulatory record management in line with standards.
• Oversee development and maintenance of SOPs and other compliance documentation.
• Collaborate with cross-functional teams to resolve compliance issues efficiently.

Skills

GCP knowledge

Regulatory inspection readiness

Cross-functional collaboration

Process improvement

Analytical thinking

Problem solving

Education

Bachelor’s degree in Life Sciences or related field

Advanced degree preferred

Tools

CTIS

ClinicalTrials.gov submissions

Record management systems

Job description

Does it excite you to work with process and SOP improvements, GCP and quality compliance and advisory, and cross-functional collaboration? Do you have experience with clinical trial processes and compliance? If this sounds like you, and you are ready to take on a broad area of responsibilities, then you could be our new colleague.

Your new position

We offer exciting responsibilities:

• Lead Clinical Trial inspection readiness activities and be an active contributor during regulatory inspections and audits
• Contribute to the development, implementation, and management of inspection readiness processes (SOPs, guides, checklists) while actively working with teams and providing internal support to ensure adherence to regulatory requirements
• Provide GCP advice and support teams in responding to inspection and audit observations
• Enhance and maintain record management adhering to regulatory and company standards
• Oversee the development and maintenance of Standard Operating Procedures (SOPs) and other compliance documentation
• Collaborate with cross-functional teams to address and resolve compliance-related issues efficiently

Your profile

You thrive in a role where structure meets curiosity, and you're motivated by turning complex regulatory requirements into clear, practical processes. You bring a strong sense of ownership, work well across functions, and are comfortable navigating both the details and the bigger compliance picture.

• Minimum bachelor’s degree in Life Sciences or a related field; advanced degree preferred
• Solid experience from a similar role within the biotech or pharmaceutical industry
• In-depth knowledge of clinical trial regulations and guidelines, including ICH-GCP, FDA, and EMA requirements
• Experience in clinical trial record management
• Preferable experience in managing CTIS & ClinicalTrials.gov submissions, including disclosure of clinical trial information
• Strong analytical and problem-solving skills, with a strategic mindset
• Excellent communication and interpersonal skills, with the ability to foster collaboration across departments
• Detail-oriented with robust project management capabilities

Your new team

Clinical Oversight and Compliance is a newly established department, anchored in Clinical Operations and growing to support all of Development. Our team of 8 specializes in processes, compliance, quality risk management, sponsor oversight, and clinical technologies and as we expand, so does our impact across the organization. We work as one team, with an informal atmosphere built on knowledge sharing and a shared drive for excellence.

Let’s bond and be bold

We have a unique culture, characterized by excellent teamwork and strong engagement across the organization. And we want you to help us strengthen this culture.

Making bonds is at the core of everything we do. From discovering and developing the best new peptide drugs for patients, to engaging with our partners or connecting with each other. We bond through curiosity and playfulness as a team, allowing ourselves to challenge common thinking and drive future innovation.

We are committed to an inclusive recruitment process and welcome applications from all job applicants.

About Zealand Pharma A/S

Zealand Pharma A/S (Nasdaq: ZEAL) is a biotechnology company focused on advancing medicines for obesity and metabolic health. Combining more than 25 years of peptide R&D expertise with a proprietary data platform that leverages advanced datadriven and AI/ML approaches, Zealand Pharma aims to lead a new era in obesity and metabolic health. To date, more than ten Zealand Pharma invented drug candidates have entered clinical development, of which two products have reached the market and three candidates are in late-stage development. The Company has collaborations with global pharmaceutical and biotechnology partners for research, development, and commercialization. Founded in 1998, Zealand Pharma is headquartered in Copenhagen, Denmark, with a U.S. presence in Boston, Massachusetts. Learn more at www.zealandpharma.com .

#LI-Onsite