Currently, we are looking for a new QA Device Senior Manager, who has experience with providing QA support to Drug/Combination Products development projects (early phase to Commercial). If this sounds like you, and you are ready to take on a broad area of responsibilities with an independent attitude, you are a match for us.
The right candidate will apply a quality mindset based on a fundament of deep QA knowledge as well as excellent collaboration skills, as ability to maintain a good relationship and oversight of internal stakeholders and of our suppliers and partners in our outsourced business model are key to our success.
You will be a part of GMP QA, which is a dedicated QA team focusing on supporting product and device activities for development and commercial products. We are working as quality assurance partners in an international environment with companies and stakeholders to ensure continuous compliance using an up-to-date knowledge of external requirements.
Responsibilities
- Be responsible for supporting our device development projects with setting direction for device quality in terms of internal and external requirements
- Providing timely quality advice for device development projects for Investigational Combination Products for Zealand Drug projects
- Daily collaboration with the Zealand Device development organization internally and external Device partners
- Develop and maintain QMS in relation to Device and Combination Product SOPs according to ISO 13485/GMP
- Participate in or lead external audits of Zealand Device partners
- Participate in preparation activities of Health Authority inspections and partner audits
- Focus on continuous improvements and simplification of our processes within Device Development and manufacturing
Candidate profile
- The successful candidate will have: A master's degree in life science, engineering, pharmaceutical sciences, or similar
- Several years of experience with Combination Products/Medical Devices in the Pharmaceutical Industry
- A least a couple of years of experience with Quality Assurance within development and/or commercial Combination Products/Medical Devices
- A result-oriented mindset and have a track record in reaching compliant solutions with a team based and collaborative attitude
- Excellent communicator skills both verbally and in writing
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/
Interested? Please apply no later than September 29, 2024, or as soon as possible. The applications will be reviewed as they come in.
For further information, please contact Senior Director GMP QA Johan Rose on Jrose@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 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 bond with us through LinkedIn @ZealandPharma.