DirecciónPrecision 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 :
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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