Be the new QA GMP Coordinator
Currently, we are looking for the right QA GMP Coordinator with compliance insight to support and oversee our GMP activities at Zealand Pharma. 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 part of a great 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.
Responsibilities
We are seeking a dedicated and detail-oriented QA GMP Coordinator to join our GMP and Device QA team consisting of 4 QP delegates and 1 Device Responsible. This team manages both clinical and commercial products, including medical devices. In this role, you will provide operational and administrative support to our GMP and Device QA Managers. You will also coordinate and oversee various quality-related activities within the department, ensuring compliance and efficiency in our pharmaceutical and device operations.
This is an excellent opportunity for someone with a quality-driven mindset who enjoys working in a collaborative environment and is eager to take on a mix of administrative and operational responsibilities.
The role includes tasks such as:
- Coordinating evaluations of deviations and change requests from Contract Manufacturing Organizations (CMOs).
- Drafting and updating SOPs, CMO Quality Agreements and other quality-related documents.
- Supporting GMP and Device QA activities, including documentation review and tracking.
- Participate in preparation activities of Health Authority inspections and partner audits.
- Assisting with the preparation and follow-up of internal and external audits within GMP, GDP and selected device requirements.
- Collaborating with cross-functional teams to ensure quality requirements are met.
- Organizing and coordinating tasks within the GMP and Device QA department to maintain compliance and streamline processes.
- Assisting with QA training sessions
- Supporting the implementation and maintenance of GMP processes in collaboration with our QA Quality Systems department.
Candidate Profile
To be successful in this role, we imagine that you either have worked in a similar position before and thrive in a coordinating and administrative role or you could be a newly graduated academic within life science, pharmacy or related field looking for your first entry level position in a fast growing biotech company.
Ideally, we hope you have:
- Have a Bachelor’s or Master’s degree in life sciences, pharmacy, or a related field, or several years of equivalent work experience in a QA or GMP environment.
- Previous experience in quality assurance or GMP operations in the pharmaceutical or medical device industry is preferred.
- Strong organizational skills and attention to detail.
- Excellent verbal and written communication skills.
- Ability to manage multiple tasks and prioritize effectively in a dynamic environment.
- A collaborative and team-oriented mindset, with a proactive approach to problem-solving.
- Familiarity with quality systems, documentation, and GMP requirements is a plus.
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 the 7th of March 2025 or as soon as possible. The applications will be reviewed as they come in.
For further information or questions, please do not hesitate to contact QA Sr Manager Martin Wallin on mwallin@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.
