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!

#LI-NC1 #LI-Remote

Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC

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.

Apply for this Job

* Required

First Name *

Last Name *

Email *

Phone *

Resume/CV *

Dropbox Google Drive

(File types: pdf, doc, docx, txt, rtf)

Cover Letter

Dropbox Google Drive

(File types: pdf, doc, docx, txt, rtf)

When autocomplete results are available use up and down arrows to review

+ Add another education

Do you have clinical research experience either working for a clinical research organization, pharmaceutical or biotech company? *

LinkedIn Profile

What is your desired salary? *

Are you authorized to work lawfully in the country/location for which you are applying? *

Will you now or in the future require Precision Medicine Group to commence (sponsor) an immigration case in order to employ you (for example, work visa application or work visa transfer, or other-employment based immigration case)? This is sometimes called "sponsorship" for an employment-based visa status. *

If sponsorship is required, confirm your current visa type:

Have you ever worked for Precision Medicine Group or one of its affiliated companies? *

If yes, when and which company?

Have you ever interviewed with Precision Medicine Group or an affiliated company? *

If yes, when and which company?

Are you currently subject to a Non-Compete or Non-Solicit with your current employer? *

I certify that the information on this application, my resume and any supporting documentation I provide is complete and accurate to the best of my knowledge. If this application leads to employment, I understand that false or misleading information in my application, resume or interview may result in my release or termination of employment. I authorize the Company or its agents to confirm all statements contained in this application and/or curriculum vitae as it relates to the position I am seeking and to the extent permitted by the laws of the country where the job is located (“Applicable Laws”). I agree to complete any required authorization forms for the background investigation. I authorize and consent to, without reservation, any party or agency contracted by this employer to furnish the above-mentioned information. I hereby release, discharge, and hold harmless, to the extent permitted by Applicable Laws, any party delivering information to the Company or its duly authorized representative pursuant to this authorization from any liability, claims, charges or causes of action which I may have as a result of the delivery or disclosure of the above requested information and all other persons, corporations, or organizations furnishing such information. If hired, I understand that I will be required to provide genuine documentation establishing my identity and eligibility to be legally employed in the country where the job is located. I also understand that the Company employs only individuals who are legally eligible to work in the country where the job is located. *

Legal Address - Street Address 1 *

Legal Address - Street Address 2

Legal Address - City *

Legal Address - State *

Legal Address - Zip *

Legal Address - Country *

Our system has flagged this application as potentially being associated with bot traffic. Please turn off any VPNs, clear your browser cache and cookies, or try submitting your application in a different browser. If this issue persists, please reach out to our support team via our help center.

Please complete the reCAPTCHA above.