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Associate Director GxP/GCP Quality Compliance

Company: Sage Therapeutics
Location: Cambridge
Posted on: February 25, 2021

Job Description:

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 Responsibilities

  • 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 approved schedule.
  • 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 change.
  • 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 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. 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 practices.
      • GCP experience strongly preferred
      • 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 continuous improvement experience (six sigma certification preferred).
      • 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 Sage Therapeutics, Inc. Get tailored job recommendations based on your interests. SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for an important role accountable for leading and driving the commercial insights, data analysis and reporting, and commercial... Location Cambridge, MA Category Research & Development Job Type Full time General Scope and Summary. Sage Therapeutics is searching for an experienced Associate Director of (DSPV) Quality, Compliance and Training that is a creative, resourceful and an integrative thinker. The... Location Cambridge, MA Category Research & Development Job Type Full time General Scope and Summary. SAGE Therapeutics is searching for a highly motivated and experienced individual for the position of an Associate Director, Health Economics and Outcomes Research (HEOR) & Value... Location Cambridge, MA Category Research & Development Job Type Full time The clinical modeling and simulation (MS) within Data Science at Sage Therapeutics is responsible for implementation of emerging quantitative methodology to support decisions in clinical development and... Location Cambridge, MA Category Research & Development Job Type Full time General Scope and Summary. Sage Therapeutics is searching for an experienced Manager of Drug Safety and Pharmacovigilance (DSPV) Operations who is a creative, resourceful, and integrative thinker. The... Share this Opportunity #ThisIsSage We are Sage Therapeutics, and we're on a fiercely committed journey of discovery, with the ultimate aim of truly enhancing the lives of people who live with CNS disorders.-- SAGE CENTRAL, the SAGE CENTRAL logo, ZULRESSO, the ZULRESSO logo, SAGE THERAPEUTICS, and the SAGE THERAPEUTICS logo are trademarks of Sage Therapeutics, Inc.All other trademarks referenced herein are the property of their respective owners.

Keywords: Sage Therapeutics, Cambridge , Associate Director GxP/GCP Quality Compliance, Executive , Cambridge, Massachusetts

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