Head of Quality

Job Purpose

The Head of Quality is accountable for ensuring Kallik is compliant with ISO 9001, ISO 27001, GAMP5, and GxP practices. This is both a leadership and a hands-on practitioner role. The Head of Quality will own and manage Kallik’s quality management system (QMS) to ensure full compliance with these standards. They will be the single accountable leader for driving quality across the whole of the company. The role will include a number of hands-on activities, such as performing internal audits as well as external audits of Kallik suppliers and other third parties, leading on the preparation and management of customer audits of the business and ensuring all software products are validated to the required standards for regulated customers.

They are also required to represent Kallik as the Head of Quality in all customer quality engagements.

The role also holds responsibility for ensuring Kallik’s compliance with health and safety legislation.

The role is required to be onsite a minimum of 4 days per week in Kallik’s offices in Birmingham.

Required experience and qualifications

  • Minimum of 5 years' experience in design, implementation & management of integrated management systems
  • Minimum of 5 years' experience in a software development environment
  • CQP PCQI accreditation or equivalent
  • Knowledge of computer systems validation: IQ, OQ, and PQ

Key Tasks and Responsibilities

Internal Quality Management

  • Formulate and manage the development and implementation of goals, objectives, policies, procedures, and systems pertaining to Quality Assurance/Quality Compliance.
  • Promote quality performance and achievement throughout the organization, and lead on the resolution of quality issues.
  • Lead, manage and coordinate Kallik’s CAPA processes
  • Ensure compliance with national and international standards and legislation, such as ISO 9001, ISO 27001, GAMP5, and GxP. 
  • Act as the owner of the QMS, performing regular audits and ensuring it is continually updated to reflect current ways of working, in alignment with the required standards.
  • Nurture a quality-centric culture in the business.
  • Plan and regularly complete internal audits to ensure compliance with the required standards.
  • Manage all accreditation assessments, ensuring Kallik achieves accreditations or recertifications. 
  • Work with the development team to ensure we deliver compliant and robust software solutions.
  • Educate employees on quality management.
  • Work with the HR Manager to ensure GxP training requirements are met.
  • Report to the Senior Leadership Team as required for Quality activities.

External Quality Management

  • Represent Kallik as the Head of Quality in all customer quality engagements.
  • Respond to any requests for audits.
  • Liaise with customers’ auditors and coordinate and support any audits which they may request, ensuring any required documentation is made available.
  • Ensure the business is sufficiently prepared for any customer audits.
  • Ensure the execution of any corrective actions and compliance with customers’ specifications.
  • Regularly complete audits, both onsite and desk-based, of key suppliers and vendors to ensure compliance with the required standards.
  • Ensure new suppliers are correctly assessed prior to the commencement of any services.

Validation

  • Oversight of Kallik’s validation processes and procedures - IQ, OQ, and PQ
Person Specification

 

To apply, please send your CV and covering letter detailing what you could bring to the role at [email protected]