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Job Details
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Senior QA Manager - New Site, build new QMS

Business Type: Pharmaceutical Company, Biotechnology Company, Contract Manufacturing
Job Type: Manufacturing - Production, Quality Assurance - Control, Validation
Job Level: Management
Position: Full Time
Location: USA - Massachusetts
Reference: 280144
Closing Date: 01/04/21
Job Details:

Are you an accomplished QA professional, ready for new challenges? Are you an expert in QMS

My client is a fast growing Biopharma company from Europe. they have just completed the construction of a new biologics manufacturing site in US. For this state-of-art facility they are looking for an accomplished Quality Assurance Professional to build their Quality Management Systems and procedures.

In this role you will be part of the senior management of the new site. You will be responsible for building the QMS for this GMP/FDA Manufacturing site. You will prepare the site for and monitor audits by the FDA. When the QMS are in place you will start to build the QA team, and manage the QA activities of the site.

This role will start as an independent role, working alone to build a system up. The role will then develop into a managerial role, as you start to build up the entire QA team.

- Build the Quality Management Systems accordig to GMP and FDA guidelines
- Ensure readiness for audits by the FDA
- Conduct internal audits
- Liaise with the European Headquarter to ensure company policies are followed

- MSc in Biochemical Engineering, or other relevant life science degree
- 5+ years in Senior QA roles in Biotech/Biopharma
- You are an expert in establishing and updating QMS following GXPs
- Experienced with preparing for and handling FDA audits
- You are living and working in USA

This role is suitable for an experienced professional ready to take the next step abd gradually build a career in management. You need to be an independent an cofident individual, not afraid to take on the responsibility for building a system from scratch in co-ordination with a Headquarter abroad.

Send your CV today or contact me via email:

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NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.

Posted: 04/03/2021 | NPJ Ref: 266860
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