The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate’s/applicant’s qualifications, skills, and level of experience as well as the geographical location of the position.

Applicants must be legally authorized to work in the United States. Sponsorship not available.

Our client is seeking a Global Quality Auditing Business Ops in Smyrna, GA.

Job Description

• Compliance Assurance:
Provide direct support to the UCB REMS Lead auditor to ensure that all REMS audits are conducted in compliance with FDA REMS requirements, contractual arrangements, standard operating procedures, and safety and welfare of patients. This includes maintaining adequate records to demonstrate that REMS requirements have been met, such as records of distribution and dispensing, certification of prescribers and pharmacies, enrollment of patients, documentation of completed Patient Status Forms and Cardiovascular Event Reporting Forms, and audits of REMS participant records.

• Audit Coordination:
Coordinate audits across various REMS implementing entities, including REMS Coordinating Center, Outpatient Pharmacy, Inpatient Pharmacies, Wholesalers, and other distributors. This involves creating audit records in advance, uploading audit documents, and managing the review and approval workflow.

• Data Management:
Monitor and manage the REMS audits group email inbox, respond to requests, and notify the UCB REMS Lead Auditor for support. Ensure proper data entry and tracking of audit reports and CAPAs in the Veeva audit system for REMS and other GxP audits run globally.

• Performance Monitoring:
Track and monitor the progress of REMS audits, ensuring timely completion and compliance with audit plans. This includes conducting daily internal audits for all dispenses against the requirements of the REMS, performing quality checks, and maintaining records for FDA inspections.

• Stakeholder Engagement:
Engage with key stakeholders and service providers involved in the REMS program to ensure effective communication and collaboration. This includes managing notifications of new enrollments within the internal REMS audits tracker and archiving enrollment forms.

Skills & Requirements

• 5 years of experience in the pharmaceutical industry within regulated areas (e.g., Research, Laboratory, Clinical, Pharmacovigilance, Manufacturing, …) and/or Quality Assurance expertise.
• Knowledge and understanding of the complexity of the BioPharma business, including drug development process, REMS and post-marketing obligations, GXP principles and digital trends.
• Proven project management, process improvement and optimization experience, with specific Quality Assurance application.
• Previous experience as Auditor is a plus.
• Communication and Interpersonal Skills: Effective written and verbal communication skills for facilitating dialogue across all levels of the organization. Effective at communicating and building relationships with team members, stakeholders, and other departments globally.
• Regulatory & Technical Knowledge: Must be knowledgeable in the global pharmaceutical industry, including the interpretation and application of applicable U.S. REMS and GxP regulations in complex situations.
• Innovation and Adaptation: Ability to innovate and adapt to changing business environments.

Benefits/Other Compensation

This position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K and Life Insurance ($20,000 benefit).

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.

Nervous about an upcoming interview? Unsure how to write a new resume?

Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays’ guiding principles is ‘do the right thing’.
We also believe that actions speak louder than words.
In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.

In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.

Drug testing may be required; please contact a recruiter for more information.

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