Job Information
Sage Therapeutics RQA Sr. Quality Associate Consultant in Remote, United States
General Scope and Summary
Sage Therapeutics is searching for a creative, resourceful, integrative thinker for an important role within the Sage Research Quality (RQA) organization to support the Risk Evaluation & Mitigation Strategy (REMS) QA audit program and clinical oversight audit activities. This individual will work cross-functionally with the REMS Compliance and Operations teams to plan, conduct, evaluate, and report compliance/audit outcomes, as well as RQA and Clinical Operation to support clinical study oversight and documentation audit activities. This individual will be critical to supporting ongoing audit commitments and ensure that the REMS program meets regulatory and business requirements.
Roles and Responsibilities (Essential Functions)
Provide quality audit support for the clinical study audit and REMS programs.
Assist in tracking and administrative close out of clinical study oversight and document audit activities.
Plan, conduct, and report on assigned REMS audits of Specialty Pharmacies (SPs), Specialty Distributors (SDs), and Healthcare Setting (HCS) to assess compliance with REMS requirements.
Assist in oversight of REMS audits of certified Healthcare Settings (HCS) to ensure they are conducted in a timely manner and meet REMS requirements; escalate and evaluate compliance critical events as appropriate.
Ensure timely issuance of audit reports and audit observations, oversee the audit response process, and drive audits to closure for both clinical study and REMS audit programs.
Ensure REMS audit CAPAs, non-compliance events, program deviations, and change controls are reported accurately and completed in a timely manner.
Ensure REMS Specialty Pharmacies (SPs), Specialty Distributors (SDs), and third-party vendors operate in compliance with the REMS requirements.
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.
Experience, Education and Specialized Knowledge and Skills
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. Must have excellent interpersonal skills, the ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, and the ability to identify issues and raise to key stakeholders in order to develop relevant and realistic plans, programs, and recommendations. Must have a demonstrated ability to translate strategy into action, excellent analytical skills, and an ability to communicate complex issues in a simple way and orchestrate plans to resolve issues and mitigate risks.
Basic Qualifications
BS/BA or science degree and experience working in Quality.
2+ years of Quality experience, specifically auditing.
Ability to travel 30-50% of the time to conduct on-site audits at HCS throughout the US.
Preferred Qualifications
A combination of Quality and technical experience (GCP, GVP, REMS, and auditing).
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)).
Experience with REMS inspections.
Experience building internal and external relationships and working with external vendors.
Excellent interpersonal and problem solving skills.
Ability to coordinate timelines with internal customers, external clients, and vendors.
Strong team player and is solution-oriented.
Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
Strong written and verbal communication skills.
Embrace our Core Values: Put People First, Improve Lives, Cultivate Curiosity, Do Right and Forge New Pathways.
Excitement about the vision and mission of Sage.
All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
This job description may not be inclusive of all assigned duties, responsibilities, or aspects of the job described. Other duties may be added, or this description amended at any time at the sole discretion of Sage.
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