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.
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- Update and improve outdated processes and SOPs.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.
- 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.
- 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.
- 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.
- 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.
- 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
|💰 Salary||£50k - £60k|