In a biotech company focused on the discovery, design and development of innovative peptide-based medicines
Zealand Pharma A/S (Zealand) aims to become a fully integrated biotechnology company leading in delivery of specialty medicines. 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 a QA Manager for Commercial Products with direct report to our QA VP. You will be a part of a QA team that covers all aspects of Quality Assurance related to Documentation, Computerized Systems, Device, Development products, Commercial products and 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.
Perhaps you already are a QP today or wish to become one. There are wide ranging opportunities in this position when you meet it with enthusiasm and Curiosity.
The successful candidate will:
- Set up and maintain the commercial QA processes for combination products, including serialization and GDP.
- Anchor and be responsible for the QA processes for commercial products including but not limited to; handling of specifications, batch release, falsified products, handling of deviating products, handling of changes, provide quality oversight of printed packaging material and maintain oversight of vendors.
- Be an expert in working with risk tools and risk management and embed these in the Zealand quality processes.
- Ensure Zealand compliance with GMP and GDP and interpret the regulations and communicate to colleagues in the organization to create solutions and reach a compliant level of operation.
- Maintain a high degree of knowledge of global industry expectations, GMP regulations and provide GMP/GDP expert support/guidance to staff in support of GMP operations
- Perform training of Zealand employees in the GMP/GDP Processes.
Some Travel activity may be expected.
The successful candidate will have:
- A master’s degree in Life Science, pharmacy or similar, with the ability of being a Qualified Person.
- A minimum of 2 years’ experience from pharmaceutical manufacturing or analytical area.
- A minimum of 5 years’ experience with Quality Assurance within manufacturing and commercial products.
- A result-oriented mindset and a proven track record in reaching compliant solutions with a team based attitude.
- A team player attitude with structural approach to compliance in an approachable manner
- Excellent verbal and written communication skills in English which is our company language.
What Zealand 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:
Zealand Pharma A/S (Nasdaq Copenhagen and New York: ZEAL) (“Zealand”) is a biotechnology company focused on the discovery and development of innovative peptide-based medicines. More than 10 drug candidates invented by Zealand have 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 and pre-clinical license collaboration with Alexion Pharmaceuticals.Zealand is based in Copenhagen (Søborg), Denmark. For further information about the Company’s business and activities, please visit www.zealandpharma.com or follow Zealand on LinkedIn or Twitter @ZealandPharma.
Please send your CV and application at the link below.
For further information, please contact Beirholm Search, Hanne Beirholm
at +45 29440080 or email@example.com