Associate Director GxP/GCP Quality Compliance
Company: Sage Therapeutics
Posted on: February 25, 2021
Associate Director - GxP/GCP Quality Compliance location
Cambridge, MA type Full time category Research & Development
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 continuous improvement efforts, by
championing organizational process and system excellence. In this
dynamic and highly visible role you will also be extensively
interfacing with both internal and external stakeholders to
position SAGE for continued future success. Roles and
- Monitor Quality Performance Indicators to assess the health of
select Business Processes.
- Manage Quality Risk Management and the Internal Audit program
across GXP functions.
- Conduct Internal Audits and Mock Inspections as per the
- Work closely with department heads to identify and quantify
risk for the organization. Facilitate risk assessments and maintain
the risk register.
- Drive Risk Mitigation and Continues Improvement initiatives by
partnering with functional stakeholders.--
- Leverage mitigating actions to drive cultural enabling
- Manage inspection readiness efforts across SAGE working closely
with subject matter experts in GCP, GVP, GLP, and GMP areas.
Maintain the Inspection Readiness Files to enable a rapid
deployment of SAGE's inspection team.
- Support the management of regulatory inspections, both on-site
and in a virtual setting.
- Enhance policies and procedures and ensure compliance with
- 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. Basic Qualifications
- B.S. Degree with 10+ years of related experience in the
pharmaceutical or biopharmaceutical industry.
- Strong working knowledge of GxP regulations
- Experience conducting internal or vendor audits as a Qualified
Auditor Preferred Qualifications
- Sound knowledge of GXP regulations and industry best
- GCP experience strongly preferred
- Excellent project management skills, teamwork, and
- Experience with all phases of the Product Lifecycle (early
stage clinical through commercial)
- Proven track record of implementing data integrity
- Experience with implementation of phase appropriate Quality
- Demonstrated continuous improvement experience (six sigma
- Past accomplishments of implementing organizational change
- 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:EmployeeNumber of Openings:1Job ID:R000482#Biotechnology
#Careers #ThisIsSageAll 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
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Keywords: Sage Therapeutics, Cambridge , Associate Director GxP/GCP Quality Compliance, Executive , Cambridge, Massachusetts
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