Quality management in scientific R&D has become an essential tool in ensuring that modern developments are implemented within a rigorous and robust quality framework. Delivered in collaboration with the Research Quality Association (RQA), this part-time MSc has been devised to meet increasing demand by the healthcare industry for senior quality management professionals.

At a glance

  • Start dateFlexible start date; enrol at any time
  • DurationPart-time MSc – up to three years, Part-time PgCert – two years, Part-time PgDip – two years
  • DeliveryTaught modules 40%, Integrated portfolio 20%, Individual research project 40%
  • QualificationMSc, PgDip, PgCert
  • Study typeExecutive

Who is it for?

Our MSc fills a major gap in the availability of quality management courses for managers, scientists, auditors and other practitioners who are aspiring to more senior roles or independent consultancy.

This course offers flexibility and support for those who wish to train whilst remaining in employment and provides delegates with invaluable access to industry professionals and networking events to help develop their careers.

Students come from the UK and the EU and usually have anything from 2 - 25 years experience in the field. This mix provides excellent opportunities for networking and exchange of knowledge.

Why this course?

This Executive MSc programme is specifically designed to help support you to fit study into your working life whilst obtaining a formal qualification in Quality Assurance. Modules are condensed as we appreciate securing time away from the office is challenging and off-campus support is available via online facilities and personal tutor support via email and telephone.

The MSc presents the core quality assurance methods, practices and processes as currently employed within the healthcare and associated sectors, whilst also looking for changing dynamics of the teams responsible for quality assurance.

The course will enable you to develop:

  • A solid foundation in regulatory requirements and standards
  • The advanced skills to manage quality teams and systems
  • The competence to deliver quality results and business performance.

Cranfield places a high emphasis on practical, transferable skills. We realise that your current or future employer will value your ability to put your knowledge and skills in to action. We give you the chance to develop indispensable team-working, project management and independent research skills. The MSc allows you to undertake an individual research project relating to quality management in industry. We are confident that this opportunity will give you a significant advantage in the field.

Class sizes are kept relatively small to help create an interactive environment and to ensure each student receives excellent support from our academic team.

Cranfield University campus has excellent transport links and several hotels and other types of accommodation options on-site making it convenient for you to attend modules.

Informed by Industry

The course retains a high relevance and currency through the relationships between Cranfield, RQA, regulatory authorities, professional membership organisations and numerous other organisations in the industry.

Your teaching team


Alongside Cranfield academics, you will benefit from a programme of visiting lecturers from industry.


Accreditation

The course is in partnership with the Research Quality Association RQA.

Course details

The formal taught component of this course comprises eight modules covering the main principles of research quality management, quality audits, risk management and quality teams. Diploma and Certificate level is also available. Diploma includes eight modules and an integrating portfolio. Certificate includes six modules. For even greater flexibility individual modules can be attended as standalone three-day short courses.

Individual project

The individual research project is an integral part of the course. It gives you the chance to apply the skills, knowledge and understanding acquired during the taught phase of the course to a practical problem in quality management. 

The project will most likely be undertaken in your place of work – benefiting both you and your employer. However, you may be able to complete this at Cranfield or possibly at another organisation and we may be able to help you find placements. This element constitutes the remaining 40% of the overall mark.

Core Principles Integration

A critical part of the course, the integrating portfolio enables you to effectively apply the theory you have gained from the taught elements of the course to your workplace. This element constitutes 20% of the overall mark.

Assessment

Taught modules 40%, Integrated portfolio 20%, Individual research project 40%

Core modules

Ethics and Regulatory Framework

Module Leader
Aim
    To provide an overview of the history and development of regulatory framework principles as they relate to the product lifecycle and an understanding of their scope, purpose and underlying ethical considerations.
Syllabus
    On successful completion of this module the student should be able to:
    • Research and identify applicable background information to support a professional assessment of a situation.
    • Use an understanding of the regulatory framework and ethical drivers to evaluate the regulatory and ethical implications of incidents of non-compliance, accurately identifying the areas of concern and potential weaknesses in oversight and regulatory control.
    • Compose a coherent, structured report, providing context and analysis.
    • Formulate recommendations for future regulatory controls aimed at better management of such situations or incidents and improving the ethical outcome, supported by coherent analysis and arguments.
Intended learning outcomes
  • Product lifecycle
  • GXP regulatory controls – their scope, purpose and historical context
  • Regulatory Inspections
  • Introduction to Bioethics
  • Human factors of compliance

Strategic Quality Management

Module Leader
  • Dr Charles Wainwright
Aim
    To recognise the importance of strategic quality management in achieving business goals.
Syllabus
    • Principles and role of QA Management Systems within the context of operational management and the overall business environment.
    • Quality planning tools and techniques for implementation.
    • Promoting and enabling quality management systems to bring about change conducive to an organisations strategic vision
Intended learning outcomes

On successful completion of this module the student should be able to:

  • Evaluate and justify the benefits of a strategic approach to quality management.
  • Plan, design and manage the implementation of quality management vision and strategy.
  • Accurately assess and manage changes to the quality management system as appropriate.
  • Demonstrate the role of a quality management system in addressing business problems.

Audit as a Management Tool for Compliance Assurance

Module Leader
Aim

    To introduce the theoretical principles of audit and audit practice to design and develop audit programs in accordance with regulatory requirements and expectations.

Syllabus
    • Audit Programmes: business context, resource management, strategy, purpose, design and monitoring
    • Auditing Principles and Practice: auditing standards, types of audit, sampling techniques, bench marking, auditing procedures, audit reporting
    • Auditor Attributes: role/accountability, skills, competencies, qualification criteria; training and development; audit and practitioner project team contribution; consultancy and training expertise
    • Audit Benefits: Root cause determination; correction, corrective and preventive action; feedback and customer satisfaction; trend analysis.
Intended learning outcomes

On successful completion of this module, students will be able to:

  • Critically evaluate the effectiveness of, audit methodologies that facilitate effective action and improvement.
  • Demonstrate an ability to design, develop, manage, and critically appraise audit programmes within the business context that meet regulatory requirements and expectations.
  • Constructively evaluate existing audit programmes and practices at work and then build, justify and defend an innovative approach to auditing.

Quality Audit Practice- Digital Quality Management

Module Leader
  • Dr Charles Wainwright
Aim

    To provide a critical evaluation of the application of information technology (IT) within regulated quality management systems and to explore the application of the principles and techniques of quality management to computer systems.

Syllabus
    • Regulations: current laws, guidelines, legal compliance; legacy systems, rationale, risk, system migration; roles and responsibilities for information technologist, management, archivist, quality assurance personnel and regulatory authority inspector
    • Suppliers and Servicers: responsibilities; documentation – records, procedures and contracts
    • Validation: Installation Qualification, Operational Qualification, Performance Qualification; verification / acceptance testing objectives, planning, test scripts, assessment, pass criteria, conclusions, reporting; change control and review; system management and personnel roles; training; records, procedures, reports
    • Quality Auditing: standards, audit programme; audit types, management, vendor/supplier, test plan and report, facility, system, operations; audit documentation; audit procedures; project team facilitation as a compliance advisor.
Intended learning outcomes

On successful completion of this module, students will be able to:

  • Critically evaluate the role of quality management in the development of computer systems and on the impact of global requirements for regulatory compliance
  • Critically assess the regulatory compliance and completeness and effectiveness of documentation of a verification study and validation for a particular computer system
  • Critically evaluate IT based audit programmes which meet regulatory requirements and expectations
  • Demonstrate knowledge of the application and control of IT in a quality system environment
  • Demonstrate an ability to design and develop an IT based audit capability within regulatory requirements
  • Communicate the quality management system requirements for computer systems simply to all levels of an organisation.

Quality Management in the Global Organisation

Module Leader
  • Dr Charles Wainwright
Aim
    To evaluate the principles and practices of management quality in a global environment.
Syllabus
    Global quality standards: common themes and key differences, mutual acceptance, harmonisation vs. localisation
    Assuring quality at a distance: subcontractor assessment and management
    Quality management integration with other business requirements
    Organisational knowledge management, transfer of information, intellectual property and due diligence
    Research business economics, global trends and driving forces.
Intended learning outcomes On successful completion of this module a student should be able to:
Critically evaluate the complexity of global quality issues and how they impact at a local level
Critically evaluate strategies for managing the quality assurance process in a variety of geographical, financial and cultural environments
Justify the formulation of business policies demonstrating corporate responsibility, having regard for business ethics, social accountability and economic activity in a global context
Formulate strategic QA processes, based on best practices for implementation.

Managing Governance, Risk and Compliance

Module Leader
  • Dr Nicola White
Aim
    To evaluate, analyse and apply appropriate GRC approaches.
Syllabus
    • The role of GRC in corporate governance.
    • Risk assessment and risk awareness tools and methodologies.
Intended learning outcomes

On successful completion of this module the student should be able to:

  • Critically appraise the suitability of an organisation’s Governance Structure and recommend and justify enhancements.
  • Evaluate the suitability of risk management models to business environments and processes.
  • Develop risk management within business functions and processes.
  • Predict, summarise and assess the outcome of a risk management process and recommend potential enhancements.
  • Integrate risk management with existing Governance and Compliance Programmes.

Managing Quality Teams

Module Leader
  • Dr Charles Wainwright
Aim

    To analyse and select most appropriate methods and resources for managing staff.

Syllabus
    • Team dynamics and composition, including type- testing/team building tools.
    • Leadership and motivation.
    • Communication and quality managements.
    • Employee performance management.
    • Grievance and disciplinary procedures.
    • Redundancy and employment termination.
Intended learning outcomes

On successful completion of this module the student should be able to:

  • Critically analyse and evaluate different team and individual type indicator methods and their application as management tools.
  • Critically analyse and apply the theoretical principles underlying the development of staff to allow effective team organisation.
  • Appraise the impact of working in multi-cultural situations and develop methods for managing cross-cultural issues.
  • Demonstrate a detailed understanding of the importance of leadership and the key role of the line manager in managing human resources.
  • Critically evaluate performance and reward management approaches in the context of the overall business strategy.
  • Demonstrate an in-depth understanding of the importance of communication skills within the quality management environment.
  • Demonstrate and apply knowledge of relevant legislation and good practice in handling employee relations within the business environment.

Business Process Development

Module Leader
  • Dr Charles Wainwright
Aim
    To identify, evaluate and implement a range of practical tools enabling quantifiable quality improvement results.
Syllabus
    • Defining, measuring and benchmarking ‘quality’
    • Evaluating quality management in other industries
    • Using quality management to establish a strategic competitive advantage
    • Analysing a business improvement culture
    • Application of business process tools
    • Audit benefits.

Intended learning outcomes On successful completion of this module a student should be able to:
  • Identify and summarise customer requirements for quality. Construct a Quality Management strategy that aligns operational performance to customer expectations
  • Critically evaluate on Quality from a range of sources, to judge the performance of the organisation
  • Assess the strengths and weaknesses of various quality improvement techniques and propose the most applicable one(s) for a range of situations
  • Recommend relevant benchmarks for the organisation from within the sector and from other sectors. Appraise data on these benchmarks to identify opportunities for improvement.

Fees and funding

European Union students applying for university places in the 2017 to 2018 academic year will still have access to student funding support.

Please see the UK Government’s Department of Education press release for more information

Cranfield University welcomes applications from students from all over the world for our postgraduate programmes. The Home/EU student fees listed continue to apply to EU students.

MSc Part-time £2,000 *
PgDip Part-time £2,000 *
PgCert Part-time £2,000 *
  • * The annual registration fee is quoted above and will be invoiced annually. An additional fee of £1,800 per module is also payable on receipt of invoice.

Fee notes:

  • The fees outlined apply to all students whose initial date of registration falls on or between 1 August 2017 and 31 July 2018.
  • All students pay the tuition fee set by the University for the full duration of their registration period agreed at their initial registration.
  • A deposit may be payable, depending on your course.
  • Additional fees for extensions to the agreed registration period may be charged and can be found below.
  • Fee eligibility at the Home/EU rate is determined with reference to UK Government regulations. As a guiding principle, EU nationals (including UK) who are ordinarily resident in the EU pay Home/EU tuition fees, all other students (including those from the Channel Islands and Isle of Man) pay Overseas fees.

For further information regarding tuition fees, please refer to our fee notes.

MSc Part-time £2,000 *
PgDip Part-time £2,000 *
PgCert Part-time £2,000 *
  • * The annual registration fee is quoted above and will be invoiced annually. An additional fee of £1,800 per module is also payable on receipt of invoice.

Fee notes:

  • The fees outlined apply to all students whose initial date of registration falls on or between 1 August 2017 and 31 July 2018.
  • All students pay the tuition fee set by the University for the full duration of their registration period agreed at their initial registration.
  • A deposit may be payable, depending on your course.
  • Additional fees for extensions to the agreed registration period may be charged and can be found below.
  • Fee eligibility at the Home/EU rate is determined with reference to UK Government regulations. As a guiding principle, EU nationals (including UK) who are ordinarily resident in the EU pay Home/EU tuition fees, all other students (including those from the Channel Islands and Isle of Man) pay Overseas fees.

For further information regarding tuition fees, please refer to our fee notes.

Funding Opportunities

Places on this course are usually either self-funded or sponsored by the student’s company. For further information please contact Enquiries. Please note that a formal offer of a place on this course must have been received before consideration can be given for funding.

To help students find and secure appropriate funding, we have created a funding finder where you can search for suitable sources of funding by filtering the results to suit your needs. 

Visit the funding finder.

Entry requirements

A first or second class UK Honours degree, or an equivalent, in a science, business or management subject, preferably with two years’ experience in a relevant role within the healthcare industry. In certain cases a blend of qualifications, motivation and relevant experience will be acceptable.

Available on a part-time basis only the course is specifically designed for industry professionals working within quality management  who would like to train to further their career or to pursue a career in the field of quality and compliance or research and development within the pharmaceutical, healthcare, biotechnology, chemical and similar sectors.

You will need RQA membership to attend this course. This can be organised during the application process.

English Language

If you are an international student you will need to provide evidence that you have achieved a satisfactory test result in an English qualification. Our minimum requirements are as follows:

IELTS Academic – 6.5 overall
TOEFL – 92
Pearson PTE Academic – 65
Cambridge English Scale – 180
Cambridge English: Advanced - C
Cambridge English: Proficiency – C

In addition to these minimum scores you are also expected to achieve a balanced score across all elements of the test. We reserve the right to reject any test score if any one element of the test score is too low.

We can only accept tests taken within two years of your registration date (with the exception of Cambridge English tests which have no expiry date).

Students requiring a Tier 4 (General) visa must ensure they can meet the English language requirements set out by UK Visas and Immigration (UKVI) and we recommend booking a IELTS for UKVI test.

Applicants who do not already meet the English language entry requirement for their chosen Cranfield course can apply to attend one of our Presessional English for Academic Purposes (EAP) courses. We offer Winter/Spring and Summer programmes each year to offer holders.


Your career

This course will enhance your career in quality management or provide you with the opportunity to pursue further research and professional development activities. It has been specifically designed to provide you with invaluable access to industry professionals and networking events - preparing you for exciting career development opportunities in any of the following sectors:

  • Pharmaceutical
  • Healthcare
  • Biotechnology
  • Chemical.

Applying

Online application form. UK students are normally expected to attend an interview and financial support is best discussed at this time. Overseas and EU students may be interviewed by telephone.

Apply Now