General Scope and Summary
SAGE Therapeutics is searching for a resourceful, integrative thinker for an important role that is responsible for Quality Risk Management, Internal Audit Program and Inspection Readiness. In this position, you will be an integral contributor to Sage's continues improvement efforts, interfacing with both internal and external stakeholders.
Roles and Responsibilities
- Manage Quality Risk Management and the Internal Audits program across GXP functions.
- Work closely with department heads to identify and mitigate risk for the organization. Facilitate risk assessments and maintain the risk register.
- Drive Continues Improvement initiatives.
- Manage inspection readiness efforts across SAGE working closely with subject matter experts in GCP, GVP, GLP and GMP areas.
- Support regulatory inspections and the drafting of responses.
- Enhance policies and procedures and ensure compliance with applicable regulations.
- Lead the Quality Management Review process.
- Implement key performance quality metrics and maintain a state of compliance.
Experience, Education and Specialized Knowledge and Skills
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, and program recommendations. 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.
- B.S. Degree with 10+ years related experience in the pharmaceutical or biopharmaceutical industry.
- Sounds knowledge of GXPs regulations and industry best practices.
- Excellent project management skills, teamwork, and collaboration skills.
- Experience with all phases of the Product Lifecycle (early stage clinical through commercial)
- Proven track record of implementing data integrity controls.
- Experience with implementation of phase appropriate Quality Systems.
- Demonstrated continues improvement experience (six sigma certification preferred).
- 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.
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.
EEO is the Law
EEO is the Law - Poster Supplement
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.
Apply on company website