OnQ Research ยท 11 hours ago
Quality Manager (remote (EU Based), full-time)
United States
Full-time
Remote
Senior Level
7+ years exp
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Responsibilities
Development and implementation of processes related to a robust Quality Management System according to GCP, GVP and GEP and ISO principles: training, deviations, CAPAs, risk and opportunity, management monitoring, lifecycle of Written Standards, among others.
Writing of SOPs and Policies.
Monitoring of Training compliance.
Development of Quality metrics.
Perform internal audits/self-inspections.
Support the company in the preparation and the conduct of external inspections.
Host audits and Regulatory Authority inspections.
Implementation and follow-up of CAPAs.
Qualification
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Required
Master degree, or PhD, in life Sciences
Minimum 7 years of professional experience in a GxP environment within the pharmaceutical industry, including minimum 5 years in a Quality position
Good knowledge of GxP principles. Knowledge and experience in working with GEP is a plus.
Demonstrate ability to design processes adapted to the needs of the business.
Ability to write clear SOPs: English writing skills, flow charts, RACI.
Experience in conducting GCP/GVP audits and hosting GCP/GVP audits and Regulatory Authority inspections.
Have the ability to find the right balance between high Quality Standards and flexibility.
Continuous improvement mindset and critical thinking.
High level of personal integrity with a strong commitment to patient welfare and ethical behaviour.
You have a keen eye for detail and good communication skills.
You can work independently (and remotely) and yet be a great team player.
You have a flexible approach to work.
You are well organized and with attention to detail while keeping a 'getting the job done' mentality.
You are client-focused.
You are focused on delivering high-quality results on time.
You are sensitive to cross-cultural differences.
Preferred
Fluent French speaking is a plus.
Knowledge of Learning Management Systems is a plus.
Experience in Vaccine development is a plus.
Company
OnQ Research
OnQ Research is a contract research organization that specializes in the execution of patient-centric clinical trials.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
unknown2023-10-16Acquired
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