Quality Analyst

• Highly Competitive compensation
• Attractive benefits (Healthcare, Pension, security, annual bonus incentive, support and well-being packages)
• Engaging employee programs
• Remote & flexible working

• Responding to & managing quality events as reported throughout the lifecycle of studies
• Manage Corrective Action and Preventive Action responses received for internal and vendor audits, and responses defined for external audit observations
• Conduct follow-up with the applicable departments to ensure timelines for corrective actions are met
• Assist with the development, generation and distribution of KPIs and other key quality metrics
• Creation and documentation of new flows, procedures, documents, training, and other support materials
• Responsible for assisting Quality Unit with updates to Standard Work Instructions and Standard Operating Procedures
• Assist with the implementation and maintenance of Quality Management Systems (QMS)
• As required, work directly with clients & sponsors to support continuous Quality & Regulatory compliance through providing consultative advice & support in managing regulatory & quality processes
• Work with the overall Quality Assurance & Regulatory Affairs team & department leaders in developing and managing continuous process improvement initiatives & projects

• BSc, MSc, or PhD in a field related to the Life Science / Pharma-Biotech industry
• Previous experience in Regulatory Affairs / Quality Assurance within a Sponsor or CRO environment is essential & a background in Clinical Research is highly advantageous to applicants
• Working knowledge of & experience working to ICH/GCP guidelines with excellent knowledge of 21CFR Part 11 &, ISO 9001/13485 regulations is essential
• Demonstrable experience working with Quality Management Systems and conducting & managing CAPA’s is essential
• Strong skills in conducting conducting/delivering Root Cause Analysis
• Excellent communication skills with the ability to work directly with international clients & teams
• Experience working in an environment associated with eCOA, Cardiac Safety, Medical Imaging, IRT/RTSM, eConsent, ePRO or other eClinical / Clinical Technologies/Solutions is highly advantageous to applicants
• Ability to work effectively as part of an integrated project team, while also taking ownership of assigned tasks to successfully achieve explicit delivery dates and milestones.
• Experience within change management and process reengineering is highly desirable

Courageously Curious

Our appetite to blend the best of domain expertise, technology and human understanding knows no bounds. We’re relentless in pursuing the information, insights and inspiration that means we can continuously improve clinical trial site support services and technology solutions.

Behaviors:

• We learn; embracing change, questioning how we work, finding a better way. And if it doesn't go to plan, we don't blame each other; instead, we own it and grow together
• We partner' with each other, with customers, patients and sites, working with them to understand their goals and then deliver the best solutions, Deliver Exceptional

We step forward because responsibility powers us; we don’t leave others to do what we can do ourselves. We take charge of events, delivering exceptional work for our customers, patients and each other.

Behaviors:

• We prioritize; focusing on what matters, never compromising on quality.
• We commit; delivering what we say we will, working with energy and intent, sharing what we learn with each other., People first, always

We think of others before we think of ourselves. We have a deep understanding of our customers, and deep empathy for patients—and each other. We’re united by our purpose—it’s why we go above and beyond to support each other, emphatically.

Behaviors:

• We do the right thing; for our customers, patients, sites and each other. And We're passionate about it.
• We lift each other up; respectful of different views, we listen are inclusive, and support each other to succeed.