Work with QA in a fast growing and exciting biotech company
Zealand Pharma is entering a new exciting era – with a strategy of becoming a fully integrated visionary biotech company with full ownership of own product candidates through late stage development and ultimately commercialization to market.
Development includes both drug and device in parallel and preparation for marketing authorization of combination products. All GxP activities are outsourced to CROs/CMOs – such as pre-clinical studies, bioanalyses and PK studies, manufacturing of Drug Substances and Drug Products as well as Finished Products, Investigational Medicinal Products, and Clinical Trial Management.
In order to meet the requirements, Zealand Pharma is looking for a QA Manager – CMC to be a part of this exciting journey.
As QA Manager – CMC at Zealand Pharma you will become a part of the QA organization overseeing all activities and delivering professional quidance to ensure GxP compliance within all areas. You will be responsible for the overall QA oversight for one of the current phase 3 products applying your knowledge within GMP. The department is headed by the Vice President, Head of QA, and in addition to this position, encompasses 7 QA colleagues. You will be reporting directly to the Vice President, Head of QA.
Your key responsibilities:
QA CMC Responsible
QP release of IMP
Ideally, you want to work with QA supporting the CMC area and hold a master’s degree within pharmacy, chemical engineering or the like. It is crucial that you have thorough knowledge of the following areas: drug development, worldwide GxP compliance regulations, research and development practices, scientific and quality terminology, quality evaluation techniques, industry quality assurance as well as management procedures and policies.
Qualifications required of the position include having a minimum of 5 years of experience working in a GxP environment in either the biotech or pharmaceutical industry. You have at least 3 years of experience in an applicable compliance related field and equivalent experience in a related R/D area working experience, where you have demonstrated a track record in operational deliverables, through project planning and managing supportive capabilities. Furthermore, you have experience from a delegated QP or QP role and experience with audits. You thrive in a role with many different internal and external stakeholders and you know the importance of good stakeholder management. It is expected that you have demonstrated good oral and written communication skills and experience within multicultural collaboration with international vendors.
You have excellent English communication skills, both spoken and written, and you are an advanced user of MS Office.
As a person, you have a high level of drive, ambition, and passion. You take initiative, are persistent, pay a high level of attention to details, and you are goal-oriented. You are comfortable with a risk-based approach to decision-making in a dynamic environment in which priorities and drivers can change rapidly. You can communicate clearly towards your stakeholders, and you are an active project player who cooperates closely with other departments at Zealand Pharma. Finally, you are quality driven, open-minded, robust, able to stand firm, and you like to have fun.
At Zealand Pharma, you will be part of a stimulating and informal innovative working environment, where you will interact with both colleagues and partners to deliver on ambitious corporate goals.
Domicile: Glostrup, Copenhagen
For more details about the job or the company, please contact Senior Consultant Jannie Jensen, Unique Human Capital on M +45 29 72 78 86. All applications must be in English and are treated confidentially.
Zealand Pharma offers an exciting, interdisciplinary, and challenging job in a workplace that encourages continuous learning at work and sharing of best practices. They have an inclusive corporate culture, where they believe in development of their employees. All employees at Zealand benefit from a combined remuneration package including pension scheme and health insurance as well as lunch plan, massage, fitness room, and social clubs.
Read more at www.zealandpharma.com