Quality Assurance Senior Manager - CDMO Biologics
- Employer
- NonStop Consulting
- Location
- Boston
- Salary
- Negotiable
- Closing date
- Mar 24, 2021
View more
- Sector
- Science, Life Sciences, Cell and Molecular Biology
- Contract Type
- Employee
- Hours
- Full Time
- Organization Type
- Corporate
- Jobseeker Type
- Professional
Job Details
My client, a high-tech biologics CDMO, are quickly growing and are now establishing a new production facility in US. They are looking for a Senior Manager Quality Assurance who will be responsible for establishing their North American processes and procedures. This is an exciting time to join and international company who is quickly growing!
Initially this position will be in charge of setting up the company QMS systems, establishing local SOPs, and hosting FDA audits. As this is the organisations beginnings in the US this role will be a standalone position with a long term view to grow as the company develops.
Key requirements:
Minimum of Bachelor's degree in a scientific discipline
- 5 - 10 years industry QA experience including managing GXP quality systems in the Pharma/Biotech industry.
- Extensive knowledge of cGMP and ICH requirements for biologics development and manufacturing
- Significant experience with establishing QMS
- Ability to independently assess R&D and manufacturing activities for compliance to regulatory standards for cGMPs
- Experience managing teams
For a confidential discussion please get in touch with Kate Dorsey by submitting your CV in WORD format at k.dorsey@nonstopconsulting.com
NonStop Consulting has been servicing the life science sector since 2001. We have operations within Boston and also across Europe. For more details of our services and areas of speciality please feel free to visit our website.
Company
Our Consultants are trained to deliver an exceptional standard of recruitment services to clients across the life sciences, chemical, care, educations, technical, digital and finance industries.
Our clients – and bottom line profits - tell us that we do a great many things very well. Complacency, however, is the last word you would associate with us. We work incredibly hard to deliver better and better results, based on stronger and stronger service delivery. Which is why we believe the best is yet to come – for us, our clients and for the people who have what it takes to join us on the journey.
The result? We’re expanding (in the UK and across Europe and even to Boston, US) and continue to post impressive performances in all our niche sectors.
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