Senior QA Manager

This position is open in one of our offices in Sweden ( Uppsala, Stockholm, Lund ), Norway ( Oslo ) and Denmark ( Copenhagen ).

LINK Medical is searching for a Senior QA Manager with a strong background in GCP, preferably combined with GMP experience. As our company continues to grow and expand its portfolio of cross-functional projects, we are looking for a highly motivated Senior QA Manager to join our team. In this role, you will work on QA projects in close collaboration with the customers ensuring compliance with applicable GxP requirements and industry standards. You will play a key role in developing and strengthening LINK Medicals QA capabilities, with a primary focus on GCP and preferably clinical-phase GMP activities according to the customer’s needs. The position also offers opportunities to contribute to business development in close collaboration with members of several teams across the LINK Medical organization.

Responsibilities

· Provide QA expertise in customer services and projects within GCP preferably in combination with GMP for clinical phase. This may include QMS development, auditing, training and advising in quality-related matters.

· Fulfilling certain roles at the customer, e.g. Quality Manager, Qualified Person (QP) as applicable, based on the competency of the consultant.

· Cooperate with colleagues in LINK Medical, nationally and internationally.

· Manage and execute projects in an efficient and timely manner and within budget.

· Develop training material and conduct internal and external training.

· Keep updated on quality-related regulations and topics.

· Contribute to the development of LINK Medical’s business for quality assurance services

Desired qualifications

· Natural science degree at college/university level

· More than 7 years’ experience from quality assurance within the life science industry

· Broad knowledge of quality assurance and regulatory requirements

· In depth knowledge within GCP in addition to knowledge within GMP and possibly other GxPs.

· Experience in auditing and quality system development

· Fluent in one of the Scandinavian languages and English

· Good IT skills and use of standard office tools

Personal characteristics

· Takes initiative, acts with confidence and works independently

· Takes responsibilities for actions and projects

· Develops job knowledge and expertise through continual professional development.

· Shares expertise and knowledge

· Demonstrates an interest in and understanding of others, motivates and builds team spirit

· Be flexible, structured, effective and customer focused.

· Identifies and creates business opportunities

· Performs high quality work while maintaining professionalism and a courteous attitude with clients and colleagues

LINK Medical offers

LINK Medical offers an exciting and challenging position in a European CRO and Regulatory Service Provider that has a strong local presence. The company focuses on collaboration, sharing of experience and continuous development of our employees. You will be given engaging assignments requiring efficient collaboration with industry partners, clinical and scientific teams and the regulatory authorities. We offer a competitive compensation and benefit scheme for all employees.

Contact information

If you would like to know more or have any questions about the position, please contact Tina Madsen, Director QA Operations ( Se e-mailadresse på careers.linkmedical.eu ). All applications are treated confidentially.

Last day for submitting your application: Se telefonnummer på careers.linkmedical.eu