Lab Quality and Process Improvement Lead

Deciphex • Oxford, NC

1d • Onsite

About The Position

You’ll be an experienced scientific and technical professional who has a good understanding of accredited histopathology laboratory operations both in the context of clinical trials and digital clinical laboratory and reporting services. This role is centered on maintaining compliance while proactively improving quality processes by preventing errors, defects, and operational inefficiencies within laboratory workflows. It involves establishing and monitoring quality metrics across laboratory processes, analysing quality data, and leading root cause investigations and continuous improvement initiatives to enhance overall laboratory performance. In addition, this role will have responsibility for implementing, overseeing and promoting the laboratory quality management system in their area. You will be successful in this role if you are proactive in taking initiative, proficient with use of new technologies, you are adept in engaging diverse stakeholders, you are innovative with problem-solving, and you have a collaborative spirit within a team environment.

Requirements

• Bachelor's degree in Biomedical Science or similar Life Science qualification
• At least 5 years of experience in ISO 15189 accredited histopathology laboratories
• Experience with digital pathology and LIMS systems
• Excellent communication, collaboration, and leadership skills
• Strong problem-solving and analytical skills.
• Ability to work under pressure and meet tight deadlines
• Experience and certification (desirable) with process improvement methodologies
• Experience with Generative AI tools and technology is a distinct advantage
• Knowledge of AI cloud computing, electronic data archiving is an advantage
• You will have shown leadership and mentoring skills in previous positions and are keen to develop these skills further by owning your role from end to end.
• You bring a sense of urgency to the work that you do and are able to execute on tasks by using your initiative.
• You enjoy innovating and bringing new ideas to the table.
• You like to have autonomy in your role and the independence to manage your own time and workload.
• You are highly collaborative and enjoy working with lots of different teams and people.
• You thrive in a fast paced environment and can manage changing priorities.
• You have great written and oral English language skills.

Nice To Haves

• Certification with process improvement methodologies
• Experience with Generative AI tools and technology
• Knowledge of AI cloud computing, electronic data archiving

Responsibilities

• Quality lead to support digital scanning and histopathology laboratory operations in the UK (Oxford and Exeter)
• Lead and coordinate data driven quality improvement initiatives by overseeing data monitoring, conducting root cause analysis, and developing improvement plans, while driving effective change management within the quality management system.
• Champion continuous improvement culture, lead implementation of various initiatives including 6-sigma, DMAIC, Kaizen etc. Train, educate and mentor staff during these initiatives.
• Evaluate and streamline existing end to end processes and procedures from customer onboarding to post delivery of services.
• Support automation and reduction of manual processes using technology.
• Develop and implement laboratory policies and procedures to ISO 15189:2022, GLP and IHC GCP requirements ensuring quality and integrity of laboratory data.
• Maintain UKAS accreditation for laboratory operations and services to ISO 15189:2022, ensuring compliance to these.
• Oversee the audit calendar for the laboratory; ensuring all internal and supplier audits are carried out in a timely manner, in liaison with the Operations Manager.
• Compile error log reports on a monthly basis & provide monthly trend analysis for KPI reviews.
• Ensure that all employees are aware of their responsibilities with regards to quality management; are adequately trained; and that all staff performing quality tasks have completed relevant competencies for performing such tasks.
• Liaise regularly with the Operations Manager on quality management issues, identify areas of concern, improvements and take action where necessary. Share learning and good practice with the other services within the company.
• Work with the Operations Manager in the provision and collation of evidence for UKAS. Assisting the Quality manager with closing non conformities and implementing corrective actions.
• Support the development and implementation of AI-assisted pathology tools for clinical and preclinical use, ensuring regulatory acceptance as applicable.
• Support any other duties as assigned by quality management
• Periodic international traveling will be required to company sites, up to 10% travel will be required.

Benefits

• Healthcare benefits
• Competitive annual leave
• A true sense of meaning in your work by contributing to better patient outcomes.
• The opportunity to work alongside a world-class high performing team in a hyper-growth startup environment.
• A chance to work on exciting,challenging and unique projects.
• Regular performance feedback and significant career growth opportunities.
• A highly collaborative and supportive multi cultural team.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior