QA Manager, Drug Substance

Job Overview

Zealand Pharma is seeking a QA Manager, Drug Substance, to join their team in Søborg, Denmark. This pivotal role involves leading and managing Quality Assurance activities for drug substance manufacturing, ensuring the highest standards are met in the development of next-generation peptide medicines. You will contribute to a mission-driven company focused on changing lives through innovative biotechnology.

Company Overview

At Zealand Pharma, we are a Danish biotechnology company on a mission to change lives with next generation peptide medicines. Bonding is at the core of everything we do, from discovering and developing the best new peptide drugs for patients, engaging with partners or connecting with each other. Ten drug candidates invented by Zealand Pharma have advanced into clinical development, of which two have reached the market. Our current pipeline of internal product candidates focuses on obesity, chronic inflammation, and certain rare diseases. Our leading obesity programs are backed by strong partners, including Roche and Boehringer Ingelheim. We are based in Copenhagen (Søborg), Denmark, with a team in the U.S.

Quick Details

• Salary Range: Market Competitive
• Job Type: Full-time
• Qualifications: None / Open to all applicants
• Experience: 10 Year+

Key Responsibilities

• Lead and manage comprehensive Quality Assurance activities for drug substance manufacturing.
• Ensure stringent compliance with GxP regulations and internal quality management systems.
• Oversee batch record review, deviations, CAPAs, and change controls specific to drug substance.
• Act as a primary point of contact during regulatory inspections and quality audits for drug substance processes.
• Collaborate effectively with R&D, manufacturing, and other departments to integrate robust quality systems.
• Drive and implement continuous improvement initiatives within the QA drug substance area.

Requirements

• Demonstrated experience in a Quality Assurance leadership role within the pharmaceutical or biotechnology industry.
• Profound understanding and application of GxP regulations, particularly for drug substance.
• Exceptional leadership, communication, and interpersonal skills to guide and motivate teams.
• Proven ability to manage complex quality systems, analyze issues, and drive effective problem-solving.
• Relevant scientific degree in Chemistry, Biochemistry, Pharmacy, or a related field.
• Experience in managing regulatory interactions and participating in quality audits.

Benefits

• Opportunity to significantly impact patient lives through innovative next-generation peptide medicines.
• Join a dynamic and forward-thinking Danish biotechnology company with a global reach.
• Work in a collaborative and scientifically driven environment focused on excellence.
• Ample professional development and career growth opportunities within a growing organization.
• Competitive salary package and comprehensive employee benefits.
• Contribute to a company with a strong pipeline of drug candidates and reputable global partnerships.