What are the responsibilities and job description for the Auditor position at Bristol Myers Squibb?
The Risk Evaluation and Mitigation Strategies (REMS) Auditor is responsible for evaluating, monitoring, and ensuring compliance with FDA?mandated REMS programs for marketed pharmaceutical products. This role conducts independent audits of internal processes, vendors, prescribers, pharmacies, and REMS program operations to verify adherence to regulatory requirements and company policies. The REMS Auditor plays a key role in identifying risk, supporting corrective actions, and strengthening the overall quality system supporting REMS execution.
Key Responsibilities
Audit Planning & Execution
Hours: Mon-Fri 8am-5pm
This posting is for a contract assignment with ASK Staffing DBA ASK Consulting to provide services to Bristol Myer-Squibb.
The starting hourly compensation for this assignment is the following range ($50- $53.24/hr). While the final, individual compensation and any available benefits will be determined by your employer of record ASK Staffing, Inc (and not BMS), factors that will be included in making the final determination may include the characteristics of the assignment, such as demonstrated experience, required skill, and the geographic location where the job is performed. The starting hourly compensation may be subject to change.
About ASK Consulting
ASK Consulting is an award-winning, woman-owned staffing and recruitment solutions provider with over three decades of industry experience. We specialize in connecting businesses of all sizes?across IT, healthcare, engineering, finance, and more?with top-tier professionals. Backed by a global network and personalized service approach, our team is dedicated to building meaningful partnerships that drive organizational success and empower job seekers to excel in their careers.
Benefits
ASK Consulting provides comprehensive, ACA-compliant health coverage, along with dental, vision, Short- and Long-Term disability for eligible employees. We also offer commuter benefits, a 401(k) plan with no matching, and a referral bonus program. In addition, ASK Consulting offers unpaid leave and paid sick leave as required by law.
Equal Opportunity Employer
ASK Consulting is an equal opportunity employer and does not discriminate against employees or applicants based on race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability, veteran status, or any other classification protected by federal, state, or local laws.
California Applicant Notice
ASK Consulting is committed to complying with the California Privacy Rights Act (?CPRA?), effective January 1, 2023, as well as all relevant data privacy laws in the jurisdictions where we recruit and hire. To learn more, please review our Notice to California Job Applicants Regarding the Collection of Personal Information on our website. Applicants with disabilities may request this notice in an alternative format by contactingHR@askconsulting.com.
Fair Chance Employment Notice
If you are selected for a position at, ASK Consulting, your offer is contingent upon successfully meeting several requirements, which may include a criminal background check. In accordance with all applicable federal, state, and local ?Fair Chance? ordinances and laws?such as the Los Angeles County Fair Chance Ordinance (FCO) and the California Fair Chance Act (FCA)?we consider qualified applicants with arrest or conviction records. The background check will evaluate whether any criminal history could reasonably pose a direct, negative impact on job-related safety, security, trust, regulatory compliance, or overall suitability for the role. Findings that raise concerns may result in withdrawal of a conditional job offer.
To learn more about how ASK Consulting collects and uses personal information during the recruiting process, please review our Privacy Notice andCCPA Addendum. As part of our recruitment efforts, we may ask you to disclose various categories of personal information, including identifiers, professional details, commercial information, educational background, and other related data. ASK Consulting will use this information solely to facilitate the recruitment process.
This posting does not constitute an offer of employment. All applicants seeking positions in the United States must be legally authorized to work in the United States. Submitting intentionally false or fraudulent information in response to this posting may disqualify you from consideration. Any eventual offer of employment will be considered ?at will,? regardless of the expected assignment duration.
Key Responsibilities
Audit Planning & Execution
- Develop and execute risk?based REMS audit plans covering all program components (e.g., training, certification, dispensing, patient counselling, data reporting).
- Conduct audits of internal REMS operational teams, third?party vendors, call centers, specialty pharmacies, and data management partners.
- Evaluate compliance with FDA requirements outlined in approved REMS programs, REMS Assessments, and the REMS Supporting Document.
- Assess adherence to SOPs, quality standards, contracts, and service?level expectations.
- Prepare detailed audit reports summarizing findings, non?conformances, and opportunities for improvement.
- Ensure accurate, objective documentation of observations in accordance with quality and regulatory expectations.
- Present audit outcomes to REMS leadership, compliance, quality assurance, and program owners.
- Collaborate with stakeholders to define root causes and develop effective CAPA plans.
- Monitor CAPA implementation, verify effectiveness, and close actions in a timely manner.
- Track recurring trends to proactively identify systemic issues.
- Participate in ongoing evaluation of REMS operational controls, including processes for:
- Prescriber/pharmacy certification
- Patient enrolment
- Documentation and data submissions
- REMS assessment reporting
- Support inspection readiness and serve as a subject matter expert during FDA inspections related to REMS.
- Contribute to continuous improvement initiatives to enhance REMS compliance and quality management systems.
- Partner with REMS Program Managers, Regulatory Affairs, Quality Assurance, Legal, and external vendors.
- Provide compliance guidance and training related to REMS requirements, audit readiness, and best practices.
- Assist in reviewing REMS materials, SOPs, and program updates for accuracy and compliance.
- Bachelor?s degree in Life Sciences, Pharmacy, Nursing, Public Health, or related field required.
- Advanced degree (MS, PharmD, MPH) preferred.
- 3?7 years of experience in biopharma, regulatory compliance, quality assurance, pharmacovigilance, or REMS operations.
- Prior GxP auditing experience (GMP, GCP, GVP) strongly preferred.
- Experience working with FDA REMS or other risk?management programs is a plus.
- Strong understanding of FDA regulatory requirements, REMS program components, and post?marketing safety obligations.
- Demonstrated audit skills, including planning, interviewing, sampling, and root?cause analysis.
- Excellent communication, documentation, and presentation abilities.
- Ability to work independently, manage competing priorities, and handle sensitive compliance issues.
- Comfort working with vendors and cross?functional teams in a highly regulated environment.
Hours: Mon-Fri 8am-5pm
This posting is for a contract assignment with ASK Staffing DBA ASK Consulting to provide services to Bristol Myer-Squibb.
The starting hourly compensation for this assignment is the following range ($50- $53.24/hr). While the final, individual compensation and any available benefits will be determined by your employer of record ASK Staffing, Inc (and not BMS), factors that will be included in making the final determination may include the characteristics of the assignment, such as demonstrated experience, required skill, and the geographic location where the job is performed. The starting hourly compensation may be subject to change.
About ASK Consulting
ASK Consulting is an award-winning, woman-owned staffing and recruitment solutions provider with over three decades of industry experience. We specialize in connecting businesses of all sizes?across IT, healthcare, engineering, finance, and more?with top-tier professionals. Backed by a global network and personalized service approach, our team is dedicated to building meaningful partnerships that drive organizational success and empower job seekers to excel in their careers.
Benefits
ASK Consulting provides comprehensive, ACA-compliant health coverage, along with dental, vision, Short- and Long-Term disability for eligible employees. We also offer commuter benefits, a 401(k) plan with no matching, and a referral bonus program. In addition, ASK Consulting offers unpaid leave and paid sick leave as required by law.
Equal Opportunity Employer
ASK Consulting is an equal opportunity employer and does not discriminate against employees or applicants based on race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability, veteran status, or any other classification protected by federal, state, or local laws.
California Applicant Notice
ASK Consulting is committed to complying with the California Privacy Rights Act (?CPRA?), effective January 1, 2023, as well as all relevant data privacy laws in the jurisdictions where we recruit and hire. To learn more, please review our Notice to California Job Applicants Regarding the Collection of Personal Information on our website. Applicants with disabilities may request this notice in an alternative format by contactingHR@askconsulting.com.
Fair Chance Employment Notice
If you are selected for a position at, ASK Consulting, your offer is contingent upon successfully meeting several requirements, which may include a criminal background check. In accordance with all applicable federal, state, and local ?Fair Chance? ordinances and laws?such as the Los Angeles County Fair Chance Ordinance (FCO) and the California Fair Chance Act (FCA)?we consider qualified applicants with arrest or conviction records. The background check will evaluate whether any criminal history could reasonably pose a direct, negative impact on job-related safety, security, trust, regulatory compliance, or overall suitability for the role. Findings that raise concerns may result in withdrawal of a conditional job offer.
To learn more about how ASK Consulting collects and uses personal information during the recruiting process, please review our Privacy Notice andCCPA Addendum. As part of our recruitment efforts, we may ask you to disclose various categories of personal information, including identifiers, professional details, commercial information, educational background, and other related data. ASK Consulting will use this information solely to facilitate the recruitment process.
This posting does not constitute an offer of employment. All applicants seeking positions in the United States must be legally authorized to work in the United States. Submitting intentionally false or fraudulent information in response to this posting may disqualify you from consideration. Any eventual offer of employment will be considered ?at will,? regardless of the expected assignment duration.
Salary : $50 - $53