QA Manager, Start-Up ATMP Biotech job in London, England

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First Name*

Last Name*

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Phone Number*

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Are you an employer or a jobseeker?*

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Good Pharmacovigilance Practice (GVP)

Location: United Kingdom

This vacancy has now expired. Please see similar roles below...

A large biotech in London has partnered with Proclincial in search for a Quality Assurance Manager. This organisation has created a technology which automates cell and gene therapy. This would the perfect opportunity to flourish at an established well know biotech.

Job Responsibilities

Support the development team in ensuring the quality and safety of the Ori platform
Manage all activities related to quality audits (internal and external including by Notified Body/FDA)
Responsible for the independent review and approval of project documentation as required by QMS
Support focus on quality at highest level of organization through organizing and leading regular Quality Updates for Senior Management
Build and support a culture of compliance through frequent and clear communication of quality policy and standards at levels within the organization
Ensure training/adherence/compliance of personnel to the QMS processes and procedures
Participate with colleagues / consultants to establish required QMS activities and planning
Provide guidance on applicable standards for development projects
Provide guidance on regulatory strategy and route to market/classification (alongside Head of Regulatory).
Support the team with improvements for the QMS to ensure compliance with relevant standards and
Experience and understanding of working with therapeutics, working within a QMS context
Proven expertise in highly quality controlled environments with safety critical development

Skills and Requirements

Relevant degree in a Life Sciences Discipline (e.g. Biology, Molecular Biology, Biotechnology etc.)
Appropriate Quality Management training and experience in managing a QMS with knowledge of relevant standards (e.g. ISO, GAMP5 etc)
3-5 years' experience in a similar environment
Desire to work in an agile, fast paced and entrepreneurial environment
IT literate, familiar with document management systems, solid XLS, PPT and presentation skills
Fluent English speaker, second language always a plus (French, German, Italian and/or Japanese preferred) if possible

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical and medical device companies.

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