QA Director - Zealand Pharma

QA Director
Zealand Pharma A/S (Zealand) is seeking a senior Quality Assurance professional who
can lead and develop the quality assurance function as our development activities
increase. Our current strategy is to take our products further in development and potentially
all the way to commercialization for selected products. We currently outsource all GMP,
GLP as well as most of the GCP activities while keeping responsibility for outsourced
activities through careful vendor selection and oversight activities.
The successful candidate reports directly to the Senior VP & COO and will work closely
with the organization and Executive Management to ensure compliance and inspection
Job profile:
The successful candidate will
 Take on leadership and management of all QA activities at Zealand
 Be overall responsible for Zealand’s Quality Management System (QMS)
 Maintain and develop Zealand’s QMS
 Update global audit plans
 Lead audits and/or select and approve auditors for Zealand’s planned GXP audits
 Lead Quality Management Review meetings for Executive Management
 Work closely with and provide guidance to project teams
 Set up and approve quality agreements
Candidate profile:
The successful candidate will have
 A MSc in Life Sciences
 10+ years of experience in a QA department in a related industry
 Expert knowledge of GMP, and preferably also GCP and GLP regulations and
 Excellent communication skills (verbal and written)
 Strong interpersonal skills
 Auditing experience with certification preferred
We are offering an exciting, interdisciplinary and challenging job with a competitive
remuneration package including pension scheme and health insurance. Zealand is a
maturing, successful biotechnology company with a stimulating and informal innovative
environment that is driven by our core values of being ambitious, curious, courageous,
passionate, and empathetic.
Please send your application and CV including two personal references no later than 25
March 2015 to:
Zealand Pharma
Att: Charlotte Madsen
Smedeland 36
DK-2600 Glostrup
[email protected]
About Zealand Pharma
Zealand Pharma A/S (“Zealand”) (Nasdaq Copenhagen: ZEAL) is a biotechnology company based
in Copenhagen, Denmark. Zealand has leading expertise in the discovery, design and development
of novel peptide medicines, in-house competences in clinical trial design and management and a
therapeutic focus on cardio-metabolic. The company has a broad portfolio of therapeutic products –
proprietary and partnered.
Zealand’s first invented medicine, lixisenatide, a once-daily prandial GLP-1 agonist for the treatment
of Type 2 diabetes, is marketed world-wide ex-US as Lyxumia and in Phase III development as a
single-injection combination with Lantus (LixiLan), both under a global license agreement with
Sanofi. US regulatory filing for both products is planned for 2015 ─ summer for Lyxumia and end
2015 for LixiLan.
Zealand is advancing a pipeline of proprietary, next-generation therapies, including danegaptide
(prevention of Ischemic Reperfusion Injury) in addition to several preclinical programs. Partnering
represents an important component of strategy to share development risk in large clinical trials, to
provide funding and to commercialize the company’s products. Zealand currently has global license
agreements and partnerships with Sanofi, Boehringer Ingelheim, Helsinn Healthcare and Lilly.
For further information:
Follow us on Twitter: @ZealandPharma