Head of Quality/Quality Manager
- Job Reference: 00026612-1
- Date Posted: 9 November 2020
- Recruiter: CV-Library
- Location: Oxford, Oxfordshire
- Salary: On Application
- Sector: Healthcare & Medical, Science & Technology, Covid-19
- Job Type: Permanent
Head of QA/RA
Are you a Head of Quality/Quality Manager who is looking for a new and exciting challenge in a fast-paced and ambitious diagnostics company? Our client is going to be a leading COVID-19 test developer and they are looking for an enthusiastic and experienced individual to lead their quality assurance strategy and bring this exciting new technology to market.
Our client is focused on building tools that allow people to make informed decisions about their health. They have developed a rapidly scalable, reliable, low-cost screening tool which can successfully screen for the biomarkers of chronic inflammation. Firstly focused on the sports recovery market, now this tool can rapidly diagnose COVID-19 using the same biomarkers; this will be the first at-home COVID-19 diagnostic tool.
Due to recent success, they are now looking for an experienced and dynamic VP of Quality/Quality Manager who will be responsible for defining, developing and deploying a quality assurance strategy which addresses all stages of product development. They are searching for people who are driven by the idea of achieving what’s currently out of reach and passionate about delivering science and technology that will enrich society. If you have this mindset and would like to bring your unique skills and ideas to our client, we would love to hear from you.
We are seeking an individual who can: -
* Own the strategic leadership of our global QARA function and our QMS.
* Ensure compliance with applicable global regulations, statutory standards and national health care compliance requirements.
* Work with cross-functional teams in the practical implementation of compliant processes to meet quality standards and requirements (e.g. key interface with notified bodies and agencies, conducting management reviews, managing PMS activities, internal and external audits including clinical sites and all vigilance activities).
* Lead regulatory strategies related to new product development, preclinical and clinical development and testing of products, and all aspects of quality.
* Ensure design documentation is created in accordance with global regulatory requirements and product life cycle standards and procedures.
* Build a highly functional team with greater capability and capacity that identifies sites, negotiates contacts, writes study protocols, monitors study progress, analyses results and works with investigators to publish.
* Identify and establish relationships with opinion leaders in the healthcare sector.
* Regulatory review and approval of marketing collateral and providing strategic advice on packaging and labelling requirements to ensure compliance.
* Support our privacy and information security function, data governance and security infrastructure.
With the following skills and experience: -
* 4+ years ISO 13485/FDA compliant Quality System management experience in Lateral Flow Point-of-Care/Medical Device/Pharmaceuticals industry.
* A detailed understanding of what it takes to ensure regulatory compliance in a manufacturing and medical business.
* In-depth knowledge of current FDA QSR, MDR, MDSAP and ISO standards.
* Experience working with cross-functional teams throughout the product development life cycle.
* Hands-on experience in co-ordinating successful regulatory submissions for various markets (EU, US, APAC, LATAM).
* Excellent organisation skills and ability to work on several simultaneous projects with tight timelines.
* Experience in auditing, preparing for inspections and privacy compliance.
Why is this a great opportunity?
This opportunity will allow you to play a key role in delivering the most accurate COVID-19 test to market.
As a start-up, our client would like you to enjoy the success of the company which you will be helping to build. You will benefit from a generous company share option program, and market salary and pension. This is a fantastic opportunity to make a real difference, not only to company success but also to the global science and technology landscape.
If you are interested in helping us change the world please send your CV to firstname.lastname@example.org Unfortunately, due to the high number of applications, we won't be able to give specific feedback to each applicant.
Location: Oxford. The client are currently completely remote and are happy for the successful candidate to work remotely. However, access to the team in Oxford would be beneficial.
* We offer a competitive salary including equity to make you a partaker of our commercial success
* We care about your personal life - we offer 22 days paid annual leave (+ 3days over Christmas), extended parental leave and health insurance