Associate Director, Research Quality Assurance
General Scope and Summary
Sage Therapeutics is searching for a creative, resourceful, integrative thinker to contribute to Quality activities in support of research projects across multiple therapeutic areas, with a focus on GVP and GCP compliance and audit activities.
Roles and Responsibilities
Assess GLP, GCP, and GVP compliance risk areas (internal and external) and develop and implement risk mitigation measures.
Develop and implement standards, policies, and procedures for regulatory compliance.
Develop and measure quality metrics to drive consistent quality standards relating to GLP, GCP, and GVP activities.
Ensure compliance with company's procedures and regulatory requirements.
Represent RQA as a single point of contact and provide QA guidance for assigned clinical study programs.
Serve as a member of the study management team with participation in the applicable forums, providing GCP/GVP/GLP 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 CROs and other GCP, GLP, and GVP service providers.
Plan and oversee GLP, GCP, and GVP audits (international and domestic), including clinical investigator site, contract clinical laboratories, CROs, and marketing partners 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 are taken to bring observations to closure as applicable.
Support investigational site inspection readiness activities.
Support key inspection activities including logistic and strategic planning, hosting, running, back-room support, and other activities as needed.
Support REMS compliance activities.
Support quality event management for assigned studies, including assessment of potential root causes and CAPA.
Maintain relevant knowledge of both local and international GCP, GLP, and GVP 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. Must have excellent interpersonal skills, the ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, and the ability to analyze complex issues to develop relevant and realistic plans and program recommendations. Must have a 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.
7+ years of Quality experience in the pharmaceutical or biopharmaceutical industry.
Demonstrated experience in Clinical Quality related to GLP, GCP, and GVP.
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 CROs, clinical sites, and investigator sites.
Understanding and application of domestic and international regulatory requirements.
Outstanding communication skills (interpersonal, verbal, and written).
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.
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.