QUALITY ASSURANCE MANAGER 🏡

Permanent
London, UK, Remote
Posted 2 weeks ago

Coders Connect 💙 are partnering with a fast-growing digital imaging and technology company 🔬 serving biotech and pharmaceutical clients, providing imaging expertise, technology and operational support to clients developing novel therapeutics using medical imaging-based markers in a multi-centre trials, who’s foundation is in software development, AI and computer science applied to medical image analysis.

✨ The Role:

Our client is looking for a person who can translate management objectives into the quality targets while encouraging and training the team. You must be people and client-focused. You will be leading the development and improvement of the quality management system and audits, as well as responsible to structure and develop a culture where everyone owns quality.

📢 Reponsibilities:

QMS & STRATEGY

  • Develop outstanding processes for clinical trial delivery.
  • Update and improve outdated processes and SOPs.
  • Develop processes and KPIs to efficiently manage quality and compliance.
  • Ensure that QMS are compliant with all recent regulations and clients’ expectations.
  • Take full accountability for maintaining, updating and managing Quality Management System (QMS) and training the team.
  • Set appropriate metrics and reports metrics to update the management team.

COMPLIANCE

  • Ensure that the delivery of clinical trials and development of our software are compliant with QMS and all legal requirements.
  • Report to the management any non-compliance.
  • Develop risk and mitigation plans.

PROCESS IMPROVEMENT

  • Preform gap analysis and assess the current QMS which incorporates GCP, 21-CFR Part 11.
  • Design, develop, implement, and assist in management of all quality assurance programs.
  • Work directly with development and operations teams to ensure the accuracy and consistency of system development and validation deliverables.
  • Facilitate quality training of peers on quality related matters as needed.

AUDITS:

  • Take full responsibility for internal and external audits.
  • Act as a quality representative for third parties.
  • Plan, conduct, and report audits’ findings according to standard operating procedures.
  • Track audit issues and/or CAPAs until closure.

💼 Essentials:

  • Bachelor’s degree in a relevant subject or comparable proven experience in a QA Management role.
  • 3+ years of relevant experience in a Quality Management role in regulated environment (21 CFR part 11, ISO 13485).
  • Experience in working within clinical research (CRO, biotech or pharma).
  • Imaging CRO and imaging device experience would be a plus.
  • Strong working knowledge of Good Clinical Practices (GCP), ICH Guidelines, GDPR.
  • Proven competency with developing and maintaining quality management systems (QMS).
  • Software Validation requirements and knowledge of ISO13485 standard would be a plus.

💥 Benefits:

  • Career development opportunities from conferences to self-guided learning, we’ll support your special interests and professional growth
  • Influence across a growing global organisation
  • A friendly, supported work environment
  • Pension contribution
  • Quarterly bonus

Job Features

💰 Salary£50k - £60k

Apply Online