GCP Compliance & Quality Auditor

RTI Health Solutions (RTI-HS), a business unit of RTI International, is an independent and internationally recognized research organization. We provide healthcare consulting and research expertise to optimize decision-making for pharmaceutical, biotechnology, and medical device products across the development and marketing life cycle. Clients rely on our expertise, quality standards, and integrity to guide their product development and regulatory and market access strategies. Our service groupings include Value, Access, and HEOR; Patient-Centered and Outcomes Research; Epidemiology and Biostatistics; Medical Communications; Global Business Operations; and Strategic Consulting and Growth. RTI-HS has office locations in the US, UK, Spain, France, and Sweden. We are currently seeking a Quality Assurance Auditor to provide oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines.

We are currently seeking a Quality Assurance Auditor to provide oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines

In this role, you will provide expertise and guidance in interpreting policies, regulations, and agency guidelines to ensure compliance. Working closely with operating entities, you will analyze processes, enforce requirements, and ensure adherence to applicable guidelines. You will also lead audit and inspection preparation, manage the resolution of findings, and serve as the primary liaison with auditing groups and inspectors throughout all audit stages.

Additionally, you will oversee the maintenance and regular updates of quality assurance programs and policies to align with evolving standards. You will implement uniform standards across global operations, promoting the sharing of best practices to advance the company's mission. Key responsibilities include conducting internal audits of non-interventional and observational research processes, offering project support, and reviewing project-related documents to uphold compliance and quality. You will also manage corrective and preventive actions to address identified issues and maintain accurate, up-to-date audit documentation.

Additional responsibilities will include but not be limited to:

• Recognizes the need for, organizes, and conducts training programs.
• Keeps current on regulations and guidance.
• Evaluates compliance with all of RTI, all applicable regulations, project policies and procedures.
• Reviews and writes standard operating procedures and QA policies, procedures, and related documents.
• Writes audit plans and audit reports.
• Conducts audits and inspections of GCP, non-interventional/observational research projects, and non-regulated documentation.
• Tracks and reviews proposals.
• Reviews and audits validated systems.

To be successful in this role, you will demonstrate the following attributes:

• Ability to prioritize multiple tasks.
• Ability to work well with others.
• Ability to listen and communicate well both verbally and in writing.
• Ability to work independently and as part of a team.
• Attention to detail and accuracy.

• Bachelor's Degree and 5 years of related experience
• Experience with GCP audits and regulatory inspections.
• Non-interventional/observational research experience.
• Excellent knowledge of MS Word, Outlook, PowerPoint, Excel.

Preferred:

• Quality Auditor Certification.

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For San Francisco, CA USA Job Postings Only: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records. Further information is available here.

RTI accepts applications to our job openings from candidates with criminal histories or conviction records in accordance with all applicable laws, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

For Applicants in Massachusetts Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

The anticipated pay range for this role is listed below. Our pay ranges represent national averages and may vary by location as a geographic differential may be applied to some locations within the United States. RTI considers multiple factors when making an offer including, for example: established salary range, internal budget, business needs, and education and years of work experience possessed by the applicant. Further, salary is merely one element to our offer.

At RTI, we demonstrate our commitment to rewarding individual and team achievement through a total rewards package. This package includes (among other things) a competitive base salary, a generous paid time off policy, merit based annual increases, bonus opportunities and a robust recognition program. Other benefits include a competitive range of insurance plans (including health, dental, life, and short-term and long-term disability), access to a retirement savings program such as a 401(k) plan, paid parental leave for all parents, financial assistance with adoption expenses or infertility treatments, financial reimbursement for education and developmental opportunities, an employee assistance program, and numerous other offerings to support a healthy work-life balance.