Currently, we are looking for a Senior QA GMP Manager with compliance insight to support and oversee our GMP activities at Zealand. 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.

You will be a part of a GMP QA team that covers all aspects of QA from product and device development to commercial medicinal and combination products. You will report to our Senior Director and Head of GMP QA.

Job Profile

You will be responsible for all QA aspects in drug substance, drug product, combination products development, and production at CMOs. The right candidate will apply a compliant quality mindset and be a team player based on a fundament of QA knowledge and a track record of development of drug products from early phase to late stage/commercial products.

Since our products are drug-device combination products a knowledge of quality assurance of device development is an advantage. The 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. The role includes tasks such as:

• QA responsible for selected development and/or commercial projects, incl drug substance, drug product, combination product and Investigational Medicinal Products to provide timely quality advice and approval
• Daily collaboration with the Zealand development organization internally and CMO's externally
• Participation in CMC project teams and/or commercial launch teams providing strategic as well as operational QA input
• Act as QP delegate and perform Batch Certification
• Participate in or lead internal and external audits within GMP and GDP
• Participate in preparation activities of Health Authority inspections and partner audits
• Maintenance and further development of the Quality System within the GMP area

Candidate Profile

• A master’s degree in life science, pharmacy, or similar
• Several years of experience with GMP operations in the Pharmaceutical Industry
• Experience with Quality Assurance work for development and/or commercial medicinal products
• Lead auditor training and experience within GMP area will be preferred
• Ability to become a Qualified Person delegate
• Result oriented mindset and have a track record in reaching compliant solutions with a team based and approachable attitude
• Excellent communication 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.