Senior Quality Assurance Specialist

3 days ago


Manchester UK, Greater Manchester, United Kingdom Square One Pharma Full time

Key Responsibilities:

  • Collaborate with the Clinical Affairs team to ensure compliance during trial activities, such as resolving deviations and complaints.
  • Represent Clinical QA as part of project teams for planned and ongoing clinical trials, including quality review of trial-related documentation.
  • Support the qualification process and perform independent QA audits of clinical study sites.
  • Participate in the internal audit program.
  • Review and update Clinical Affairs SOPs.


Position Requirements:

  • Degree qualification in a relevant field or equivalent work experience.
  • Proven experience and knowledge of clinical regulations, standards, guidelines, and best practices (e.g., CFR 812, BIMO, ISO standards, ICH GCP).
  • Solid understanding of global In Vitro Diagnostic Regulations (e.g., EU IVDR, US 21CFR820).
  • Ideally a qualified auditor with experience serving as a Subject Matter Expert during regulatory inspections and formal audits (e.g., NB audit).
  • Willingness to travel internationally (up to 10%, including Europe and the US).
  • Ability to work independently with good judgment and decision-making within established policies and practices.
  • Strong communication and interpersonal skills, with the ability to work effectively in multinational and multicultural teams.



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