LinkedInMichael Britt

Michael Britt

Head Knowledge and Technologies Management at Roche Products Ltd

Location
Stevenage, United Kingdom
Industry
Pharmaceuticals
Current
  1. Roche Products Ltd
Previous
  1. Roche Products Ltd,
  2. ClinPharm,
  3. Hoechst UK Ltd
Education
  1. Sheffield Hallam University
309connections

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309connections
Roche Products Ltd

Roche Products Ltd

Head, Knowledge and Technologies Management

– Present

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Background

Summary

An individual with substantial experience in the areas of GCP Quality and Computerised Systems Validation. An Experienced Project and Program Manager in multiple domains (Pharmaceutical and non-Pharma).

An effective leader and manager who is skilled at developing and implementing strategy.

Well regarded for having a pragmatic and helpful approach and always seeks to find the positive in any situation.

Used to working under pressure. Experienced auditor (ISO9001 Internal Auditor certification).

Experience

Head, Knowledge and Technologies Management

Roche Products Ltd
– Present (2 years 2 months)UK

Provides strategic direction and management of all Knowledge Management activies in Clinical Quality; Responsible for managing all technical solutions from conception to use; Leading a team developing training for use within Quality; Providing the infrastructure needed by other Quality groups to enable efficient work; Developing standard methods and frameworks to enable consistent work

Global Head Quality Risk Management

Roche Products Ltd
(1 year 3 months)UK

Lead and managed the Quality Risk Management (QRM) Group; Established a new leadership team; Developed Mission and Vision for department and created an operating charter; Ensured work was resourced effectively and efficiently; Collaborated with ‘customers’ of Quality to refine services and ensure that Risk Management was embedded into processes and practices

Global Head GCP / PV Quality

Roche Products Ltd
(8 months)UK

Managed and lead the Global Quality group of 170 people on ad interim basis providing GCP and PV Quality services.

Global Head, Validation

Roche Products Ltd
(7 years 11 months)UK

Lead and managed a group of around 20 to deliver Computerised Systems Validation services to the GCP and PV departments

Site Head Systems Validation

Roche Products Ltd
(3 years 5 months)UK

Provided consultancy and support on Computerised Systems Validation; Project management of validation projects; Development of validation SOPs; Coaching and advice to IT professionals on validation methods; Ensuring compliance with regulatory and company requirements

Head of Statistical Programming

ClinPharm
(6 years)Maidenhead

Statistical input to study design and protocol; Statistical analysis and reporting; Project Management; Pharmacokinetic analysis and consultancy; Production and maintenance of statistics, data management and IT SOPs; Financial implications and costing; Statistical consultancy; Client Liaison (including business development); SAS programming; Ensured smooth working practices between statistics and data management functions; Programming clinical trial databases in MS Access; Verification & validation of data; Acted as IT Manager for 4 years.

Biometrician

Hoechst UK Ltd
(2 years 7 months)Milton Keynes, United Kingdom

Statistical input to Phase I study design and protocols; SAS programming; Statistical analysis and reporting of Phase I studies; Pharmacokinetic evaluation; Responsible for maintaining standards of SAS programming within group; Harmonisation of CRF design within Hoechst Europe; Project Managed the re-write of an in-house software application; Acted as Deputy Head of Phase I statistics.

Programmer

HM Treasury
(6 months)London

Redeveloped major system from SPSSX to SAS working within a UNIX environment; Provided answers to ad-hoc requests; Produced replies to Parliamentary Questions as required; Passed the Civil Service Open Contest Interviews and offered permanent posting.

Volunteer Experience & Causes

Opportunities Michael is looking for:

Causes Michael cares about:

  • Environment
  • Health
  • Science and Technology

Organizations Michael supports:

Publications

Computerised Systems Validation in Clinical Research

ACDM
2005

A joint cross-Pharma effort to bring a common sense guideline to practitioners of CSV

Skills

  • GCP
  • Clinical Trials
  • Validation
  • Protocol
  • Sop
  • Clinical Development
  • Computer System...
  • CTMS
  • Clinical Study Design
  • 21 CFR Part 11
  • Pharmaceutical Industry
  • CRO
  • GxP
  • SAS
  • Data Management
  • Biotechnology
  • Clinical Data Management
  • ICH-GCP
  • CAPA
  • EDC
  • Change Control
  • FDA
  • SOP
  • Quality Assurance
  • Quality Management
  • See 10+  See less

Education

Sheffield Hallam University

Bachelor of Applied Statistics, Statistics

At Sheffield I was able to extend my knowledge of Statistics. Subjects covered ranged from Survey Design & Analysis, Multivariate Methods, Exploratory Data Analysis, and Statistical Programming

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