Become Our Next Senior QA IT Manager, QA IT
Join a biotech company committed to discovering, designing, and developing innovative peptide-based medicines. We are currently looking for a Senior QA IT Manager to join our QA IT team. In this role, you will help ensure the integrity and compliance of our IT infrastructure and systems as well as ensuring IT oversight of computerized systems used as part of our clinical trials.
You will be welcomed as a part of our ambitious and passionate Zealand family working seamlessly and effectively in a fast-paced environment providing life changing medicines.
Responsibilities
As a Senior QA IT Manager, you will:
- Ensure that IT systems supporting pharmaceutical operations comply with internal quality standards, regulatory requirements and best practices (e.g., FDA 21 CFR Part 11, EU GMP Annex 11, GxP).
- Act as the Quality partner in implementation projects of GxP IT systems and oversee their ongoing maintenance.
- Develop and maintain quality standards for regulated IT systems.
- Ensure oversight of computerized systems used by our CROs in Zealand clinical trials.
- Conduct audits of IT suppliers and CROs to ensure compliance with regulatory expectations.
- Lead initiatives for the continuous improvement of IT quality standards and processes.
- Collaborate closely with IT, Quality, and Clinical teams to optimize systems and processes from a quality perspective.
Candidate Profile
We are looking for someone with:
- A degree in Computer Science or a related field.
- At least 5+ years of experience in IT Quality Assurance or IT compliance roles within the pharmaceutical or regulated industries, with a focus on IT systems, software validation, or data integrity.
- Experience as an auditor, preferably with a Lead Auditor certification.
- In-depth knowledge of regulatory requirements related to IT systems in the pharmaceutical industry (e.g., 21 CFR Part 11, EU GMP Annex 11 and GAMP5).
- Hands-on experience with IT system validation, risk management, and audit processes in a regulated environment.
- Strong communication and collaboration skills to work effectively with cross-functional teams, including IT, Quality, Clinical, and Regulatory departments as well as external partners.
- A detail-oriented mindset, strong analytical skills, and the ability to solve complex quality issues.
What We Offer
- The opportunity to work in a fast-paced environment providing life-changing medicines.
- Professional development and the chance to contribute to innovative projects.
- Limited travel requirements (approximately 15–20 days per year for supplier audits).
Join us and make a difference in advancing peptide-based medicines that improve lives.
Bonding to innovate
Our employees are fundamental to our success, and we continue to be able to attract and retain people with vast experience and talent. We have a unique culture, characterized by excellent teamwork and strong engagement across the organization.
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 as a result of our entrepreneurial culture where our people are encouraged to pursue their ideas and turn them into reality. We are curious about each other’s knowledge and expertise. We bond through curiosity and playfulness as a team, allowing ourselves to challenge common thinking and drive future innovation. Zealand Pharma is a place where everyone is heard and contributes to the success, we all want to experience. The Zealand Pharma DNA builds on four values: (1) We are bold, (2) We empower people, (3) We work as one team, and (4) We can be trusted.
Let’s bond and be bold
We offer a combined compensation package which includes a base salary, pension, bonus, and a possibility to join our employee share program. We care about our employees’ well-being and offer health insurance, use of massage, fitness, and a range of social clubs and activities
To find out more about working at Zealand, visit https://www.zealandpharma.com/careers/zealand-as-a-workplace/
Has this sparked your interest? Please apply no later than 16th of February 2025, or as soon as possible. The applications will be reviewed as they come in.
For further information or doubts, please do not hesitate to contact Head of QA IT, Kamilla Vagtborg (kvagtborg@zealandpharma.com)
About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq Copenhagen: ZEAL) ("Zealand") is a Danish biotechnology company on a mission to change lives with next generation peptide medicines. In our effort to reach our goals bonding is at the core of everything we do. Let it be discovering and developing the best new peptide drugs for patients, engaging with partners or connecting with each other. This has led to more than 10 drug candidates invented by Zealand having advanced into clinical development, of which two have reached the market. Zealand’s current pipeline of internal product candidates focus on specialty gastrointestinal and metabolic diseases. Additionally, the portfolio includes clinical license collaboration with Boehringer Ingelheim. Zealand is based in Copenhagen (Søborg), Denmark. For further information about the Company's business and activities, please visit www.zealandpharma.com or bond with us through LinkedIn.
