Would you like to join our growing organisation?
- Gentian AS
- Vice President Quality Assurance and Regulatory Affairs
Gentian is an ambitious and fast-growing diagnostic company looking for a new Vice President Quality Assurance and Regulatory Affairs. We are looking for a new strong and dedicated manager to lead our Quality Assurance and Regulatory Affairs department in order to meet our strategic goals for the future. As the VP QA/RA you are the management representative in the quality management system.
This position is included in the Gentian management team, and will have the departmental responsibility for all processes and operations within quality assurance and regulatory affairs. The successful candidate needs to be an inspiring leader who is passionate about processes and wants to make a difference in a smaller, entrepreneurial company.
- Overall responsibility for all aspects of the QA/RA department
- Contribute to the development of strategic goals and quality objectives
- Advise CEO and other department managers on QA/RA matters
- Ensure all processes are progressing accordingly to plan
- Responsible for being updated on new, changed and revised standards and regulations, and implement necessary changes to the quality management system
- Collaborate with other department managers for implementation and maintaining our quality management system
- Support all departments with QA/RA expertise
- Responsible for improvement projects related to quality and regulatory affairs
- Planning and control of the department cost
- Responsible for the electronic quality system
- Overall responsibility for the department’s achievement of KPI and achieve quality objectives
- Ensure that the quality policy is maintained at all levels
Professional experience and qualifications:
The ideal candidate should have successful track record in a senior leadership role within quality assurance and regulatory affairs.
Required experience include:
- MSc within Scientific discipline; Biochemistry, Biology, Pharma, Chemistry, Physics, Engineering or other relevant areas
- Experience in management role with strong management skills
- Minimum 5 years of experience from the life science industry
- Strong knowledge in FDA regulations and guidelines
- Knowledge with IVD EU Directive
- Strong knowledge in GMP, ISO 9001/13485
- Experience with auditing
- Experience with Six Sigma/Lean is an advantage
- Experience in execution and project management
- Knowledge of the immunochemistry technologies and market is an advantage
- Good English skills both written and oral
- Proficiency in standard business software (Word, Excel, Outlook, PowerPoint)
- Strong manager experience
- Is experienced and motivated by changes and improvements rather than status quo
- Is mature, self-confident and have strong interpersonal skills
- Has strong leadership and organizational skills
- Is flexible and adaptable to change
- Has the ability to manage multiple and sometimes conflicting priorities with effective communication and resource allocation
- Has the ability to develop and deliver presentations, and is an effective communicator
- Has the ability to communicate and interact with officials at all levels and to work effectively with a wide range of constituencies in a diverse community
- Is willing to work with flexible schedule and some travel
We can offer:
For the right candidate we offer an exciting career opportunity in an innovative and fast-growing global company. We offer great potential for personal and professional growth with good conditions and competitive wages.
Please send CV and application letter in English.
Gentian AS develops and market high quality, in vitro diagnostic assays for the global clinical laboratory market, both human and veterinary. Gentian´s products have gained substantial market share due to their high quality from utilising our proprietary, innovative technology for nanoparticle enhanced diagnostic tests. Gentian performs production, R&D, marketing and distribution from our headquarters in Norway, Moss and our representative offices in China, Sweden and US. The company coordinates several well-funded international R&D projects partnered by leading clinical and commercial organisations using our nanoparticle-based technologies. Several exciting and original diagnostic products are in the pipeline, and new employment opportunities are being created. Today Gentian employs 40 persons of varied age, professional background and nationality.
QA/RA, Quality, Regulatory, IVD
|Sist endret||24. sep 2019 12:44|