Risk Evaluation & Mitigation Strategy Auditor
Temp-to-Hire - REMOTE
POSITION SUMMARY: This position will play a key role within Risk Evaluation & Mitigation Strategy (REMS) QA audit program and work cross-functionally with the REMS Compliance and Operations teams to plan, conduct, evaluate, and report compliance/audit outcomes. The auditor will be critical to supporting on- going audit commitments and ensure that the REMS program meets regulatory and business requirements.
ESSENTIAL FUNCTIONS: The responsibilities of this job include, but are not limited to, the following:
- Plan, conduct, and report on REMS audits of Specialty Pharmacies (SPs), Specialty Distributors (SDs) and program vendors to assess compliance with REMS requirements.
- Lead oversight of REMS audits of certified Healthcare Settings (HCS) by liaising with approved third parties to ensure they are conducted in a timely manner, meet REMS requirements, and escalate and evaluate compliance critical events, as appropriate.
- Maintain the approved supplier list (ASL) for REMS suppliers.
- Ensure timely issuance of audit reports, audit observations, oversee audit response process and drive audits to closure.
- Evaluate audit observation trends and escalate as required.
- Maintain and enhance existing procedures that are utilized to manage the REMS audit program.
- Conduct internal audits to assess effectiveness of REMS QMS and process compliance.
- Be a key contributor to REMS Regulatory Inspections and support authoring of annual assessment reports, as required.
- Responsible for providing quality audit support for the REMS program.
- Ensures REMS Specialty Pharmacies (SPs), Specialty Distributors (SDs) and third-party vendors operate in compliance with the REMS requirements.
- Ensures audit CAPAs, non-compliance events, program deviations and change controls are reported accurately and completed in a timely manner.
- Lead specific REMS compliance initiatives aimed at strengthening the program, as required.
- Collaborate with REMS Strategy and Execution, and Channel teams to ensure audit CAPAs and non-compliance events are elevated appropriately and addressed in a timely manner.
- Ensure REMS quality incidents are fully investigated, root cause identified, and CAPAs are appropriate, have been implemented and are monitored for effectiveness.
- Provide data to assess risks, generate quality metrics and review lessons learned as requested.
- Reporting of key metrics (KPIs), periodic quality reports, and audits as required.
- Other responsibilities as assigned.
- REMS audits conducted meet all regulatory compliance requirements.
- Sustain a culture of quality at all key REMS suppliers.
- Escalation of compliance risks to senior management.
- Maintaining current working knowledge of regulations that impact role.
- Bachelor of Science or Bachelor of Arts degree in a life science. Post graduate degree is preferred.
- REMS auditing experience preferred; however other GxP auditing experience will be considered.
- Understanding of regulatory requirements for the implementation and maintenance of a REMS compliance program.
- Understanding of REMS guidelines.
- Experience authoring compliance sections of REMS Assessment Reports is preferred.
- Practical application of regulatory requirements (e.g. 21 CFR Part 210 and 211, and 21 CFR Part 11, 505-1(REMS)), and DEA Regulations (21 CFR Part 1310).
- Prior experience working with contracted third parties is preferred.
- Experience with REMS inspections is desired.
- Demonstrated ability to identify and implement continuous improvement initiatives.
- Experience in auditing Pharmacovigilance and / or Clinical activities is preferred.
- CQA or other auditing certification, is preferred.
- Ability to travel with adequate notification approximately 30% of working hours is required.
In addition to the minimum qualifications, the employee will demonstrate:
- Strong interpersonal and communication skills (written, listening and oral).
- Ability to communicate clearly to all levels of the business and deliver concise written or oral summaries to management.
- Ability to develop and maintain positive internal and external professional relationships by consistently delivering core values.
- Influencing skills in areas with no direct reporting authority.
- Strong planning and organization skills.
- Auditing skills, appropriate qualifications in auditing an advantage.
- Motivated by delivering high quality patient treatments in the arena of addiction.
- Proficient in English. However, fluency in other languages is advantageous.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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