Senior Quality Associate Consultant, Research Quality Assurance

Location
Working from Home
Posted
Nov 23, 2021
Ref
R000919
Required Education
Bachelors Degree
Position Type
Full time

General Scope and Summary

Sage Therapeutics is searching for a creative, resourceful, integrative thinker for an important role within the Sage Risk Evaluation & Mitigation Strategy (REMS) QA audit program. This individual will 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 ongoing audit commitments and ensure that the REMS program meets regulatory and business requirements.

Roles and Responsibilities

  • Provide quality audit support for the REMS program.

  • 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.

  • 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. 

  • Ensure timely issuance of audit reports and audit observations, oversee the audit response process, and drive audits to closure.

  • Ensure 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.

  • Lead assigned REMS compliance initiatives aimed at strengthening the program, as required.

  • 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.

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.

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, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.

  • Excitement about the vision and mission of Sage.

Employment Type:Contingent Worker

Number of Openings:1

Job ID:R000919

#Biotechnology #Careers #ThisIsSage

All Sage new hires will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief.  Requests for accommodation will be considered on a case-by-case basis, and Sage will consider, among other things, whether the proposed accommodation would create an undue hardship.

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.

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We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Sage Therapeutics, Inc.