Sage Therapeutics Director, Quality Assurance - GCP/GLP in Cambridge, Massachusetts


General Scope and Summary

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

Roles and Responsibilities

  • Plan and lead GCP and GLP audits (international and domestic), including clinical investigator sites, contract clinical laboratories, and CROs to determine compliance status and identify compliance risks.

  • Assess GCP and GLP compliance risk areas and develop and implement risk mitigation measures.

  • 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.

  • 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

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, programs and 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.

  • Bachelor’s degree with minimal 12+ years’ experience in Biotech or Pharma and 7+ 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 of domestic and international regulatory requirements.

  • Outstanding communication skills (interpersonal, verbal and written).

  • Proven track record of industry success.

  • Strong leadership and management skills; experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.Strong team player that has a customer service approach and 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.

  • Possesses 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.

ID 2018-2131

# of Openings 1

Category Quality/Regulatory