BE THE NEW

Senior Manager, GCP QA

in a biotech company focused on the discovery, design and development of innovative peptide-based medicines

Currently, we are seeking a proactive, and structured Senior Manager in the GCP QA team, who possesses a relevant academic background (MSc) and at least 5 years of experience working within development QA or Clinical Trial Research. If you are ready to take on a broad range of responsibilities with an independent and collaborative attitude, you are the perfect match for us.
In Zealand QA, we are a team of 14, serving as Quality Partners for the GLP, GCP, GMP and IT areas internally, while also performing quality oversight of Zealand suppliers. The position is located at our headquarters in Søborg. The new Senior Manager will be part of the GCP QA team, reporting to the Senior Director, GCP QA.

Responsibilities

Plan, perform and follow up on audits within the clinical GCP area, both internally and for external providers (e.g., CROs and clinical trial sites).
Support the development of Clinical Development procedures within Zealand Quality System and act as the QA on deviations and CAPAs.
Actively participate in planning, hosting, and follow-up on Regulatory Inspections.
Provide GCP expert compliance advice to the organization.
Share knowledge on global industry standard and expectations.

Candidate profile

The successful candidate will possess most or all of the following qualifications:

A master’s degree in life science, pharmacy, or a similar field.
5 years of experience in Quality Assurance, Clinical Trial Research or Clinical Trial Supplies.
Highly motivated result-orientated individual who enjoys working in collaborative environments. You value inter-departmental team relationships using your excellent interpersonal and communication skills.
Thrive in an ever-changing biotech environment.
Structural approach to compliance in a pragmatic and approachable manner.
Excellent communication skills in English, 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 March 15, 2024, or as soon as possible. The applications will be reviewed as they come in.

For further information, please contact Senior Director, Helle Maach-Møller at +45 5060 3687 or hmaachmoller@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 or Twitter @ZealandPharma.