Sage Therapeutics

Associate Director, Quality Assurance (GCP/GLP)

Job Locations US-MA-Cambridge
Posted Date 1 month ago(2/19/2018 11:14 AM)
# of Openings



General Scope and Summary

SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for an important role that is responsible for GCP and GLP compliance and audit activities.

Roles and Responsibilities

  • Plan and lead GCP and GLP audits (international and domestic), including clinical investigator site, contract clinical laboratories, and CROs to determine compliance status and identify compliance risks.
  • Assess GCP and GLP compliance risk areas (internal and external) and develop and implement risk mitigation measures.
  • Assist and provide guidance for regulatory inspection readiness activities.
  • Ensure compliance with company's procedures and regulatory requirements.
  • Conduct QA reviews of project-related Clinical Development essential documents (e.g. protocols, amendments, case report forms, tables and listings, informed consents, investigator brochures, and Clinical Study Reports).
  • Review and provide input into non-clinical documentation (e.g. protocols, study reports).
  • Facilitate GCP/GLP training of functional areas and develop appropriate training for personnel involved in the execution of clinical trials and nonclinical studies.
  • Participate in the evaluation and selection of CROs and other clinical and nonclinical service providers. 
  • Provide guidance, interpretation and information on GCP and GLP regulations, standards and quality systems to Sage functional areas
  • Develop and implement standards, policies and procedures for GCP/GLP regulatory compliance.
  • Develop and measure quality metrics to drive consistent quality standards relating to GCP and GLP activities.

Experience, Education and Specialized Knowledge and Skills

  • Bachelor’s degree with minimal 10 years’ experience in Biotech or Pharma and 5+ years’ experience in Quality Systems related to GCP and GLP.
  • Strong analytic skills with practical knowledge of how to identify key performance quality metrics to set targets for maintaining a state of compliance while identifying areas for improvement.
  • Extensive experience auditing clinical CRO’s, clinical sites and investigator sites.
  • Understanding and application of domestic and international regulatory requirements.
  • Outstanding communication skills (interpersonal, verbal and written).
  • Proven track record of industry success.
  • Strong leadership and management skills.
  • Excellent teamwork and collaboration 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.



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