Manager or Head of Quality

Reports to: Chief Medical Officer

Location: Hybrid: London Bioscience Innovation Centre, Kings Cross, London, UK, as well as homeworking

Prokarium is looking for an experienced Manager/Head of Quality to join our diverse and high-performance team based in central London. Under the direction of the CMO, and in collaboration with the VP Research you will be responsible for the development, implementation and management of the electronic quality management system and all quality related activities.

Key Responsibilities

  • Transition company’s quality systems from paper QMS to eQMS (development, implementation and management)
  • Review processes and systems on an ongoing basis to determine where improvements can be made
  • Organise and take charge of SOP management and review (including training record management)
  • Work alongside the Clinical Operations team and provide GCP QA support and guidance as required
  • Coordinate GxP audits of external service providers by consultant auditors
  • Implement and manage a document archiving system for all submission documents inclusive of a full audit trail
  • Implement internal audit and CAPA strategy and track QMS activities, including CAPAs and deviations, and the implementation of corrective actions
  • Lead HTA licence application, ensuring full compliance with the support of the Lab Manager
  • Health and safety committee member responsible for all quality aspects of company’s H&S
  • Establish record retention policy and archiving for company communications (Outlook/Teams)
  • Provide advice and support to functional operational teams

Qualifications and Experience sought

  • Scientific degree or equivalent
  • At least 5 years GxP experience in the pharmaceutical industry
  • Strong interpersonal and collaboration skills; ability to be highly productive and flexible in a team-oriented, fast-paced environment
  • Ability to build positive relationships and work collaboratively both with internal team members, vendors and other external third-parties
  • Strong computer skills
  • Flexible in reacting to changing priorities in a dynamic business environment
  • Knowledge of current GxP requirements within major pharmaceutical markets (particularly the application for investigational medicinal products)
  • Knowledge and application of the principles of the Quality Management Systems (QMS) and continuous improvement
  • Excellent planning and organisational skills; effective time management skills

Traits sought

  • Adaptable
  • Self-starter
  • Excellent interpersonal, communication and facilitation skills
  • Ability to work effectively with internal/ external partners.
  • Collaborative approach and mindset
  • Excellent verbal and written communication and computer literacy skills
  • Proven ability to present credibly to senior management/Board.
  • Ability to work effectively in an agile company, with a fast-paced, team-based environment.

Personal Attributes

  • High ethical standards and transparency
  • Trustful and high level of integrity
  • Results driven, proactive and self-motivated
  • Agile and Non-bureaucratic
  • Creative and insightful
  • Excellent interpersonal skills
  • Team player
  • Strategic thinking and strategic planning skills