Senior Project Quality Associate Consultant, RQA

Location
Working from Home
Posted
Nov 05, 2021
Ref
R000991
Discipline
Quality, Quality Control
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 that 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 ensuring that the REMS program meets regulatory and business requirements.

Roles and Responsibilities

  • Lead assigned REMS program initiatives aimed at strengthening the program.

  • Create/mange project timelines, status reports, and project dashboards for REMS program initiatives.

  • Partner with key stakeholders and functional leads to drive assigned REMS program change and communications needs across the organization.

  • Provide data to assess risks, generate quality metrics, and review lessons learned as requested.

  • Perform reporting of key metrics (KPIs), periodic quality reports, and audits as required.

  • Assist in the oversight of REMS audits of certified Healthcare Settings (HCS) to ensure they are conducted in a timely manner and meet REMS requirements, and escalate and evaluate compliance critical events as needed.

  • Perform Quality audit support for the REMS program as needed.

  • Perform 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 to orchestrate plans to resolve issues and mitigate risks.

Basic Qualifications

  • BS/BA or science degree and experience working in Quality.

  • 3+ years of Quality experience, specifically in auditing.

Preferred Qualifications

  • A combination of Quality and technical experience (Project Management, PV, and REMS).

  • 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 11 and 505-1(REMS)).

  • Experience building internal and external relationships and working with external vendors.

  • Excellent interpersonal and problem solving skills.

  • Ability to coordinate timelines with internal customers and external clients and vendors.

  • Strong team player that 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:R000991

#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.