Zealand Pharma A/S (Zealand) is a fully integrated biotechnology company leading in delivery of specialty medicines with the first New Drug Application in review with the FDA. We are passionate about improving the quality of life for patients with metabolic and gastrointestinal diseases, and other specialty or rare disease areas with significant unmet medical needs.
Zealand is now seeking an IT and System QA Manager with compliance insight to GxP IT systems, GxP system validation and daily maintenance. You will be a part of a strong QA team that covers all aspects of QA from Documentation, GxP IT, Device, GMP and GCP. 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.
The successful candidate will be responsible for:
Be the Quality Assurance IT responsible for creating and implementing a process for oversight of vendor’s and their subcontractor’s critical GxP IT systems.
Ensure initial evaluation and continued oversight of vendors and their subcontractors’ critical GxP IT system
Partner with Zealand IT department to develop, improve and approve qualification of Zealand GxP infrastructure and drive inspection readiness activities
System Responsible on GxP systems in Zealand Pharma:
Serve as System responsible/ application manager to implement and maintain GxP systems, including a new Serialization system.
System responsibility includes system implementation in close collaboration with Zealand users and software vendors
Define and execute on System lifecycle activities related to upgrades, bug fixes, user groups, procedure writing, change preparation and implementation and assuring a validated and compliant status in close collaboration with users and vendors throughout the system lifecycle
Charter and drive progress in System steering groups
Handle and develop the quality system on GxP systems in Zealand Pharma
Support Regulatory Inspections
Act as System Responsible backup for other GxP systems
The successful candidate will have:
5+ years in experience with GxP IT systems in the pharmaceutical/biotech industry
3+ years as QA for GxP IT systems
Experience with Cloud based software and IT infrastructure qualification
Practical experience with FDA 21CFRpart 11, EU Annex 11, and GAMP 5.
Strong practical knowledge of GxP and authority inspections.
Bachelor degree in Pharmacy, Librarian, Engineering, science or similar
A compliant and structural yet practical mindset
Strong communication skills also in English
Highly collaborative mindset, empathy, and interpersonal skills
Energy and drive for team results
Ability to work effectively in a fast paced environment
What we offer
Zealand’s employees are one of the company’s most important assets. We strive to attract, develop and retain the best talents, and to be a company where every employee can thrive.
At Zealand, we understand the value of a diverse workforce. As an employee, you will be part of an innovative, cross-disciplinary and cross-cultural working environment.
We offer a combined salary package including pension scheme and health insurance, as well as the option of joining the company lunch program, and use of massage, fitness and social facilities.
To find out more about working at Zealand, visit our careers site and view our company video at:
Please send your cover letter/CV no later than July 5, 2020.
Candidates will be invited to interviews on an ongoing basis
, so please do not hesitate to apply
For further information, please contact Sr. Manager, QA Systems and Support, Pernelle Quist at +45 5060 3621 or PQU@zealandpharma.com.
About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq: ZEAL) ("Zealand") is a biotechnology c
ompany focused on the discovery, development, and commercialization of next generation peptide-based medicines that change the lives of people living with metabolic and gastrointestinal diseases. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market. Zealand’s robust pipeline of investigational medicines includes three candidates in late stage development, and one candidate being reviewed for regulatory approval in the United States. Zealand markets V-Go®, an all-in-one basal-bolus insulin delivery option for people with diabetes. License collaborations with Boehringer Ingelheim and Alexion Pharmaceuticals create opportunity for more patients to potentially benefit from Zealand-invented peptide therapeutics.
Zealand was founded in 1998 in Copenhagen, Denmark, and has presence throughout the U.S. that includes key locations in New York, Boston, and Marlborough (MA). For more information about Zealand’s business and activities, please visit