Be the new
QA Commercial Products Manager
in a biotech company focused on the discovery, design and development of innovative peptide-based medicines
Zealand Pharma A/S (Zealand) is a fast-growing, fully integrated Copenhagen-based biotechnology company with a highly attractive pipeline. With one product on the market, one candidate in registration and six candidates in the clinical pipeline, Zealand is a unique success story in Danish biotech. 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. In addition to the Søborg Headquarters, Zealand is also located in the United States in Boston (MA), Marlborough (MA), and New York (NY).
Zealand is now seeking a QA Manager for Commercial Products with compliance insight to support and oversee a compliant quality system at Zealand, 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.
Responsibilities includes helping us to:
The successful candidate will have most or all of the below qualifications:
- Driving the set-up of the commercial QA processes for devices and combination products, including serialization and GDP.
- Anchor the QA Processes for commercial product including but not limited to; handling of specifications, batch release, complaint handling, falsified products, handling of deviating products, handling of changes, provide quality oversight of printed packaging material and maintain oversight of vendors.
- Being an expert in working with risk tools and risk management and embed these in the Zealand Pharma quality processes.
- Ensuring 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.
- Maintaining 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.
- Planning, performing and following up on internal and external audits within GMP.
- Perform training of Zealand Pharma employees in the GMP/GDP Processes.
- Travel are expected to be up to 15 % time, adjusted to current Covid-19 travel restrictions.
What we offer
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.
- A master 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 have a track record in reaching compliant solutions with a team based attitude.
- Lead auditor skills within GMP and GDP and hands on experience with Inspection.
- Computer Validation skills on an expert level.
- A teamplayer attitude with structural approach to compliance in an approachable manner.
- Excellent communication skills verbally and in writing in English which is our company language.
Our work environment is characterized by strong cross functional team-work, room for individual performance and development, informality and respect, high work-ethics and engagement, and fun.
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 compensation package which includes a base salary, pension, bonus, and an attractive warrant 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 our careers site and view our company video at:
Please apply no later than 1 September, 2020.
For further information, please contact VP & Head of QA, Charlotte Tvermoes Rezai at +45 5060 3686 or CRezai@zealandpharma.com
About Zealand Pharma A/S
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.