Associate Director, Research Quality Assurance

General Scope and Summary 

SAGE Therapeutics is searching for a creative, resourceful, integrative thinker to conduct Quality activities in support of research projects across multiple therapeutic areas with a focus on GCP and GVP compliance and audit activities.

Roles and Responsibilities

• Assess GCP, GVP, and GLP compliance risk areas (internal and external), develop and implement risk mitigation strategies.
• Ensure compliance with company's procedures and regulatory requirements.
• Represent RQA as a single point of contact and provide guidance for assigned clinical study programs.
• Serve as a member of study management teams with participation in the applicable forums, providing GCP and GVP compliance advice and guidance to achieve continuous quality improvement and effective quality assurance.
• Interface with Sage functional areas, including regulatory, clinical, and development sub-teams, as appropriate to provide guidance, interpretation, and information on regulations, standards, and quality systems.
• Participate in the evaluation and selection of contract service providers (CROs) for GCP and GVP activities, as well as other service providers, e.g., audit consultants.
• Plan and oversee clinical investigator site audits to determine compliance status and identify compliance risks.  Upon audit completion, communicate results to the relevant stakeholders, and interact with various teams to ensure corrective and preventative actions (CAPA) are taken to close observations as applicable.
• Lead key inspection activities including logistic and strategic planning, back-room support, investigational site inspection readiness and other activities as needed.
• Develop and implement internal standards, policies, and procedures to ensure regulatory compliance.
• Develop and measure quality metrics to drive consistent quality standards relating to GCP and GVP activities.
• Support quality event management for assigned clinical programs and/or studies, including assessment of potential root causes and CAPA.
• Maintain relevant knowledge of both local and international GCP, GVP, and GLP requirements and development as they impact Sage standards.

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 identify issues and raise to key stakeholders in order 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.

Basic Qualifications

• Bachelor’s degree
• 6+ years’ experience in Biotech or Pharma
• 4+ years’ experience related to Quality activities

Preferred Qualifications

• Demonstrated experience in Clinical Quality related to GCP and GVP.
• Experience in GLP is a plus.
• 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.
• Experience auditing clinical CRO’s, clinical sites, and investigator sites.
• Familiarity with data integrity controls.
• Understanding and application of domestic and international regulatory requirements.
• Outstanding communication skills (interpersonal, verbal and written).
• Proven track record of industry success including experience supporting regulatory inspections.
• Strong leadership and management skills.
• Excellent teamwork and collaboration skills.
• Embrace our core values: Put People First, Improve Lives, Cultivate Curiosity, Do Right, Forge New Pathways.
• Excitement about the vision and mission of Sage.

All Sage new hires will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief.  Requests for accommodation will be considered on a case-by-case basis, and Sage will consider, among other things, whether the proposed accommodation would create an undue hardship.

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.