Join us in redefining what it means to work for a CRO. Working at Rho, you’ll be joining a team who take healthcare and clinical research personally, with shared experiences that drive a passion to heal, cure and solve some of humanity’s biggest challenges.

At Rho, we’re committed to you just as you’re committed to us. You’ll have the opportunity to experience a thriving company with real stability - financial, workforce, and corporate, which has created a safe environment to innovate and develop over a long and rewarding career. With a collaborative team of smart, talented, and positive people, you’ll be celebrated and respected for your expertise and given the freedom to think creatively, challenge the norm, and problem-solve.

We are currently hiring a Senior Quality Assurance (QA) Auditor with strong expertise in Good Clinical Practice (GCP) to join our team!

As a Sr. QA Auditor, you will use you expertise and in-depth, working knowledge of GCP compliance and other applicable regulations and laws in order to help build a Culture of Quality at Rho. To accomplish this, you will, first and foremost, be responsible for hosting sponsor audits of Rho to secure new business, improve processes and compliance, and ensure timely re-qualification for our commercial and federal clients. Secondary, you will have the opportunity to support our clinical and biometric project teams as they execute their work, prepare and support regulatory inspections of Rho, our sites, and our sponsors, as well as independently plan and conduct internal and external audits.

Our Quality Assurance Team will tell you, joining Rho has been one of their best career moves in terms of contentment, financial rewards and career growth, which is why we have such stability in the group!

• Plan, coordinate, and host sponsor audits of Rho, including the oversight of Rho’s responses to audit findings from initial response through delivery of promised processes changes.
• Assist the organization in preparation for the coordination, hosting, conduct, documentation and follow-up of regulatory inspections.
• Evaluate internal compliance with company procedures, policies, programs, initiatives, GCP, and applicable regulations.
• Lead and/or assist audit activities including clinical site audits, key document audits, and software and system validation documentation audits.
• Conduct audits of clinical trial vendors providing services such as central imaging, central laboratory services, ECG, IP management and distribution, IRT, ePRO/eCOA, and EDC systems.
• Assist in the creation, review, revision and management of procedural documents.
• Clearly communicate and report (verbally and in writing) audit outcomes and escalate significant compliance concerns to project teams, QA and Rho management, and sponsor contacts.
• Maintain significant knowledge in regulatory requirements and ICH GCP principles.
• Provide regulatory compliance guidance and quality improvement consult to internal and external customers.
• Report, manage and follow deviations, complaints, issues, non-conformances and their related CAPAs.
• Assist in the management of contract auditors.
• Support business proposal preparation and defense.
• Prepare training materials and conduct training related to relevant QA topics.

• Bachelor’s degree in life sciences or a related field as well as 4 years in the biotechnology, medical device or pharmaceutical industries, which includes 3+ years of increasingly responsible experience in clinical (GCP) quality assurance.
• Certification in auditing, clinical research, or regulatory affairs (RQAP, CCRP, RAC, etc.) preferred.
• Prior experience with an eQMS preferred.
• Candidate must possess strong Excel, Word, and PowerPoint skills. Experience with SharePoint is preferred.
• Available and willing to travel as needed for on-site audits, approximately 10%.
• Strong Communicator: Demonstrate written, verbal and presentation skills to help showcase the successes of your work and Rho’s.
• Committed to Quality: Every job at Rho requires an attention to detail, a deep understanding of our high-quality scientific standards, and an ability to care about every outcome.
• High-Character: Contribute to our collaborative culture with honesty and integrity. At Rho, we value a strong team spirit highlighted by loyalty, accountability, and mutual trust. We work smart together, we work hard together, and we laugh together. We take responsibility for our actions, forgive honest mistakes and respect one another.
• Critical Thinker: Rho values thinking. Draw on your native analytical thinking and ingenuity, sharpened and enhanced by our intellect, training, and experience. We evaluate situations and opportunities objectively and incisively; we then craft novel, practical solutions.
• Agile and Adaptable: Rho values the ability to change quickly. We eagerly anticipate, respond to, and take advantage of changes in our environment. We embrace risk but manage it by planning, prioritizing appropriately, accepting, and learning from both failures and successes. The opportunity to adapt and evolve energizes us.

A few more things to know about us:

Benefits: Rho provides a comprehensive benefits package for all benefit-eligible employees, which includes medical, vision, dental, HSA, FSA, EAP, life & disability insurance and 401(k). All employees are eligible for paid time off, holidays, parental leave and bereavement leave.

Diversity and Inclusion: As a global, full-service CRO driven by our collective experiences, we view each of our backgrounds as a vital component in our formula for success and we strive towards building a more equitable, inclusive, and diverse environment for our employees every day. By valuing and tapping into each employee’s unique and different personal experiences, we are able to uplift employee dignity and belonging, foster more strategic creativity, and more quickly arrive at breakthrough solutions that help us heal the world.

Flexibility: We encourage a work-life balance that allows employees to bring their best selves to work while being passionate about their lives outside work.

 EOE. Veterans/Disabled

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