QA Manager – CMC
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
- Employ GxP QA expertise during the development providing GMP compliance guidance to internal stakeholders
- Influence the compliance of projects and programmes
- Review and approve internal and external documentation
- Ensure that the CMC Quality Management System at Zealand adheres to applicable regulations and guidelines by QA approval of SOPs
- Participate in NDA readiness program within CMC
- Ensure compliance with applicable regulations and quality standards for GMP pharmaceutical operations related to manufacturing, testing, packing and distribution of investigational drug products, investigational API and investigational devices
- Prepare Quality agreement for development GMP vendors
QP release of IMP
- Accountability and responsibility for the release review process of DP and review release of IMP including sponsor approval
- Provide QP Quality/Influence the compliance of projects and programmes
- Provide QA guidance to third party vendors to ensure quality of API DP and IMP vendors
- Participate in relevant GMP audits
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.