Position Summary:
The Senior Quality Auditor supports the audit program and clinical projects to ensure compliance with regulations and Precision procedures. Responsible for providing oversight and subject matter expertise to quality and compliance activities, supporting project teams during all stages of a clinical study.
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 and company policies and procedures
- Additional tasks as required
Qualifications:
Minimum Required:
- 4 years industry 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
Other Required:
- Bachelor’s degree in a science, healthcare, or related field of study; combination of qualifications and equivalent relevant experience may be accepted as an alternative
- Availability to travel up to 25% 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
- 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
- Results oriented, accountable, motivated and flexible
- Demonstrates values and a work ethic consistent with Precision Values and Company Principles.
- Excellent verbal and written communications skills
- Fluent in English language and for non English speaking countries, the local language of country where position is based
Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.
Reasonable estimate of the current range
$80,000—$120,000 USD
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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.
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 [email protected].
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
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What We Do
We founded Precision Medicine Group in 2012 because we believed there was a transformational opportunity to improve the process of bringing new drugs to market. It involves utilizing technology, data, and human expertise. It is a big challenge that requires diverse talents. Our model involves both nurturing and investing organically and acquiring capabilities that we do not have but critically need. Our core executive team is anchored to this model, building life science services that address fundamental changes in healthcare that are necessary for health and outcomes improvement.
