English
Pharmetheus is a diversified Life Sciences consultancy partner at the forefront of the application of quantitative approaches to drug research, development, and usage. We operate in the area of biosimulation and biotech, using software to describe biological processes.
We offer consulting services focused on the application of quantitative approaches to support drug research, development, and life-cycle decisions. With our expertise in model-informed drug development, pharmacometrics, and PBPK-QSP, we support clients from strategy to design and analyses. At Pharmetheus, we are promoting a culture of innovation and collaboration where diversity and inclusivity are highly valued, and where everyone feels supported and empowered.
Pharmetheus’ main premises is in Uppsala, Sweden. However, our physical footprint stretches beyond Uppsala through our office network in Basel, Paris and Utrecht and home office networks in Europe and North America.
For more information, visit the company´s web sites at www.pharmetheus.com
Quality Assurance Officer
Do you want to work for a global Life Science consultancy company, with its origins in Sweden? Pharmetheus is in an exciting development phase, with a high growth rate, and with a potential to continue to grow! We are looking for an experienced Quality Assurance Officer responsible for the continuous and strategic development of the QA function. Pharmetheus offers both MIDD (Model Informed Drug Development) services and products to its clients and as such your role is an important and vital assurance of Pharmetheus’ regulatory compliance.
The Quality Assurance Officer ensures that Pharmetheus’ processes comply with regulatory requirements and that Pharmetheus’ services meet the clients’ expectations of quality. The Quality Assurance Officer leads the Compliance Team which currently consists of representatives from our Clients Operations, Business Operations and IT, including direct line management responsibility and support of a Quality Assurance Specialist, currently being recruited. The Quality Assurance Officer reports directly to the CEO.
This is an opportunity to continuously challenge your skills in a developing and supportive environment. You will be part of a research-driven company that is unique in its market and that actually contributes to improving people's health.
Main duties & responsibilities
● Ensure compliance with regulatory requirements and guidelines such as International Council for Harmonization Guideline for Good Clinical Practice (GCP)
● Oversee, develop, implement, and maintain an evolving quality management system (QMS) to ensure consistent quality and compliance
● Conduct internal audits to identify areas for improvement and assess compliance with regulatory requirements and Pharmetheus’ quality management system.
● Host client audits and inspections by regulatory agencies.
● Evaluate and monitor vendors to ensure that they meet quality requirements.
● Coordinate and investigate quality issues to identify root causes and ensure issues are addressed and resolved through corrective and preventive actions.
● Oversee the validation of GxP critical computerized systems and review the documentation.
● Provide training and education to Pharmetheus associates on regulatory requirements, industry standards, and Pharmetheus quality management system.
Profile
We are looking for a highly skilled and motivated person with robust Quality Assurance experience working with clinical Quality Assurance in a regulated setting combined with understanding of business acumen. You need to have knowledge and experience of GCP and QMS development. You also need to have good cooperation and communication skills. It is important to be well organized, with excellent planning and time management capability and to have a strong sense of ethics and principles with pragmatic thinking, to be able to deliver in this important role. Independent, flexible, accurate and solution-oriented are other important properties that are crucial to be successful in this position.
Qualifications and experiences
● Minimum 7 years of work experience from a company within life science.
● Minimum 5 years of experience within Quality Assurance.
● Experience from leadership of Quality Assurance teams and processes.
● Good knowledge about the Harmonization Guideline for Good Clinical Practice.
● Speak and write fluent English
● Excellent reading, writing, and language skills
● Proven experience in project management or line management. It’s meritorious if the experience has been from a knowledge-intensive consultancy setting
Opportunities with the role
Pharmetheus offers an exciting and challenging position and an inspiring working environment. We are a motivated, dedicated, and growing group of close to 100 employees. We offer a workplace with an atmosphere characterized by a high level of flexibility and a great team spirit. Our highly skilled and enthusiastic team brings considerable value to clients and partners, intending to improve patients’ lives.
Contact
For more information and questions about the position, please contact Marta Frick Senior Recruitment Consultant at PeakSearch.
Contact details:
marta.frick@peaksearch.se Tel: 070-386 89 69