Senior Quality Auditor Remote, United States

Precisionscientia; United States; Remote; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Senior Quality Auditor to enhance compliance and quality assurance in clinical projects. This pivotal role involves overseeing audit programs, supporting project teams, and ensuring adherence to regulations and internal procedures. The ideal candidate will have a strong background in quality management systems and clinical research, with excellent communication and problem-solving skills. Join a dynamic team dedicated to maintaining the highest standards in clinical trials and quality assurance, where your expertise will contribute to impactful healthcare solutions.

Benefits

Health insurance

Retirement savings benefits

Life insurance

Disability benefits

Parental leave

Paid time off for sick leave

Paid vacation

Discretionary annual bonus

Qualifications

• 4 years of industry experience required, with clinical research experience considered.
• Strong knowledge of GCP/ICH guidelines and FDA regulations essential.

Responsibilities

• Support the Quality Management System and maintain documentation for controlled documents.
• Conduct internal audits and coordinate vendor assessments and audits.

Skills

Interpersonal skills

Problem-solving skills

Effective verbal communication

Effective written communication

Computer skills

Knowledge of GCP/ICH guidelines

Knowledge of FDA regulations

Microsoft Word proficiency

Microsoft Excel proficiency

Microsoft PowerPoint proficiency

Education

Bachelor’s degree in a science or healthcare field

Tools

Electronic clinical trial systems (EDC, CTMS, IxRS, ePRO)

Job description

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
• Maintain 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:

• 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
• 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
• 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

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.