Senior/Principal Quality Auditor at Precision for Medicine
London, United Kingdom
Job Descrption
Precision for Medicine is hiring a Senior/Principal Quality Auditor to join our team, candidates can be based in either UK, Spain, Hungary, Poland, Romania, Serbia or Slovakia.
Position Summary: The Senior/Principal Quality Auditor supports the audit program and clinical projects to ensure compliance with regulations and Precision procedures.
Essential functions of the job include but are not limited to:
Support the Quality Management System including SOPs, training and CAPA
Process and maintain documentation for controlled documents, as required
Develop and administer training for employees and/or consultants
Host client/sponsor audits and support regulatory inspections
Coordinate and conduct assessments of potential and contracted vendors, including vendor audits as warranted
Coordinate and conduct internal audits of quality systems
Coordinate and conduct investigator site audits
Coordinate and conduct trial master file audits
Participate on computer systems validation projects and systems change control process
Provide QA consultation and support to assigned project teams internally and externally
Support and manage reported quality issues and any associated corrective and preventive actions
Monitor quality systems to provide feedback on compliance risks to QA management and identify opportunities for improvement
Maintains Q&C trackers, databases, metrics, and files
Follow applicable regulations and standards, including but not limited to local regulations (US FDA and EU), ICH, ISO and company policies and procedures
Additional tasks as required
Qualifications: Minimum Required:
Requires two to five years of applicable experience or equivalent combination of education and experience
Clinical research experience in non-QA role considered (e.g., clinical research associate experience)
Working knowledge of GCP/ICH guidelines and FDA regulations and standards
Hands-on experience leading clinical site audits
Other Required:
Bachelor’s degree in a science, healthcare, or related field of study
Availability to travel up to 50% domestically and/or internationally
Preferred:
CRO, Pharmaceutical and/or Medical device experience
QA certification preferred (e.g., CQA, SQA, etc.)
Experience with electronic clinical trial systems (e.g., EDC, CTMS, IxRS, ePRO, etc.)
Skills:
Excellent interpersonal and problem-solving skills, effective verbal and written communication, computer skills
Competencies:
Strong knowledge of GCP/ICH guidelines and FDA regulations and industry standards
Intermediate proficiency in Microsoft Word, Excel, and PowerPoint, and some knowledge of Access or similar database
Must possess a customer service demeanor; demonstrate collaboration and flexibility, teamwork, and a keen attention to detail
Ability to work independently and in a team environment
Ability to work with cross functional groups and management under challenging situations
Ability to prioritize work and handle multiple and/or competing assignments
Excellent verbal and written communications skills
Must be fluent in the English language
At Precision for Medicine, we believe that the era of one-size-fits-all medication is giving way to a next generation of treatments, medicines that will be more effective because they are prescribed according to the unique biology of an individual patient. Our mission is to help innovative biotech and pharmaceutical companies accelerate the development of these life-changing treatments. Precision does this by developing assays that utilize biomarkers to help identify the right patient for the right drug. We handle every aspect of clinical trials from initial strategy and design to selecting sites and executing quality clinical trials. This is where you come in!
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If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
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