Quality Management System Manager

On behalf of our client in Central London Pop Science is delighted to offer the position of QMS Manager to join their team in central London. This role would suit an innovator who is looking to move to a young company where there is exposure for everyone at all levels.
Founded in 2011 by Pharma industry experts that specialise in providing data quality and data capture analysis to Pharmaceutical companies. Their development of a web-based application allows them to work within the fields of technology, research and the life science sector. This newly created position will be a stand-alone head of department role but no direct reports right away. 

Here's an idea of what you will be doing:

The QMS Manager is responsible for supporting a robust Quality Management System
and will ensure that continuous improvement initiatives are championed.
The QMS Manager is responsible for ensuring that all software and infrastructure provided
to customers in a GxP impacted environment is maintained in a verified state in
accordance with the requirements of the applicable rules, regulations and guidelines, and industry standards, such as GAMP 5.
You will work with the team's onsite where necessary to ensure that the operating company is maintained in a position of being ready for customer audits.
As the QMS Manager you will be involved with the routine activities associated with the
requirements of the General Data Protection Regulations (GDPR)

To maintain training records for self.
Quality Management System (QMS) - to follow, review and assist in the improvement
of the QMS in the quality function ensuring that the following activities are carried out
* To assist in the implementation and maintenance of policies and procedures to
control the validation of software applications and the qualification of hardware
infrastructure in a software development environment.

QA Operations - to ensure that the following activities are carried out:

* Ensuring that processes needed for the Quality Management System (QMS) are
established, implemented and maintained.
* Ensuring that the QMS, and associated documentation, meet all required internal and
external Quality and Compliance standards.
* To ensure all System Testing/Verification/Validation is performed in accordance with
International Guidance's.
* Approval of Quality documentation on behalf of the company
* Liaise with customers regarding quality/compliance topics as required
* Preparation and management of customer inspections and on-site audits, including all
follow-up activities and remedial actions as necessary
* Ensure that appropriate assessments/audits of suppliers and technology partners are undertaken and correctly documented
* Report to the QA Director (/CEO) / Quality & Security Committee on the performance
of the QMS and any need for improvement. Ensure improvements are fully assessed
and implemented as necessary, following the agreed internal change management
processes
* Providing appropriate guidance/mentoring to ensure all staff have an understanding
of GxP and how the requirements should be applied
* Partnering with the various departments to ensure that all aspects of their SaaS product meet the standards required by Life-Sciences organisations operating within a highly-regulated environment
* Acting as system manager/administrator on key company support systems (eQMS,
Training, Document Control) ensuring their continued operation in accordance with appropriate regulations and customer requirements.
* Preparation of key procedural documents, and provision of input to other staff, to
ensure that they meet internal and client requirements. Ensure implementation of
new or updated documentation follows a consistent path and that relevant staff
receive training
* Ensuring that all Corrective and Preventative Actions (CAPAs) are documented and
resolved in a timely manner
Information Privacy and Security
* To ensure that documentation associated with information governance is current and
accurate

You should recognise yourself here:

* Relevant experience in an IT-related field or Quality Assurance position within Clinical Research / Life Science Industry
* Familiarity with international regulations as applied to the Life Science Industry -
Good Clinical, Laboratory, Manufacturing, Pharmacovigilance Practices
* Understanding of GAMP guidance and the requirements for computer systems
validation (CSV) as applied to vendors developing and supporting cloud based SaaS
systems
* Knowledge of software quality principles and familiarity with Agile style Systems
Development Lifecycles
* Experience of managing internal and external audit programs.
* Demonstrated problem-solving and analytical skills. Good troubleshooting skills and
strong attention to detail
* Strong written and verbal communication
* Graduate in Life-Sciences subject(e.g. Pharmaceutical Sciences, Biology, Pharmacy…)
or Computer Sciences discipline
* 5yrs+ experience of applying quality systems in regulated software development
industries
* Knowledge and understanding of Medical Devices regulations would be an advantage

Pop Science are an innovative, personal and experienced recruitment and staffing consultancy. Our aim is to make science more popular by championing careers in clinical and scientific research, technology, engineering, maths and more. Whether you want a permanent job, a contract role or even a change in perspective with some volunteering, contact us and let us help you. We support working practises that promote happiness at work.

We're an experienced, skilled team with personality; we have a passion for science, and drive and enthusiasm to make a difference to you.

Find out more at Pop Science - Scientific Recruitment

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