Sage Therapeutics Associate Director, DSPV Quality, Compliance & Training in Cambridge, Massachusetts
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 AD will assist with the establishment and maintenance of the Global Quality System for DSPV that supports Sage products in compliance with FDA and ICH Guidelines and international regulatory requirements.
The successful candidate will have a proactive and innovative approach and a flexible, hands-on nature that works with a high sense of urgency. Responsibilities also include assisting in the successful development and implementation of a DSPV Training Program and ensuring compliance with global regulations across all Pharmacovigilance functions. Effective communication skills will be key as this role provides an excellent opportunity for close collaboration with colleagues from other functions such as Clinical Operations, Medical Science, Data Science, Regulatory Affairs, Quality Systems, Medical Affairs and Legal.
Roles and Responsibilities
Direct line management for the Manager of Compliance & Training or other direct reports
Establish and define annual goals for direct report(s) that are aligned with Sage Corporate goals. Ensure direct reports have defined goals related to professional growth and development. Actively provide ongoing evaluation of goals throughout the year utilizing the Sage checkpoint process.
Develop and maintain a robust onboarding curriculum for new quality, compliance and training staff.
Actively participate in the interview process and onboarding of all new DSPV members, as applicable.
Represents DSPV as a leader on cross-function teams and committees.
Compiles monthly KPIs and metrics for review by DSPV Leadership
Monitors KPIs and metrics for compliance trends
Escalates any potential compliance risk for the department or the company at large to the Head of DSPV.
Participates in regular touch base sessions with Research Quality Assurance (RQA)
Actively participates in DSPV internal audits and health inspections.
Responsible for the coordinated response for DSPV operations internal audits or health inspection findings and implementing corrective actions.
The point of contact for the DSPV safety vendor regarding quality and compliance issues
Collaborates with the DSPV safety vendor to ensure all deviations are well documented to reflect accurate root cause and appropriate corrective actions are defined and implemented.
Manages internal deviations and collaborates with RQA representative to mitigate the risk
Responsible for the maintenance of the safety vendor Quality Management Plan
Tracks noncompliance issues related to the retrospective review for trends and collaborates with DSPV Operations for any necessary corrective action.
Actively participates in Inspection Readiness activities
Standards & Training
Develops and maintains policies and procedures for the DSPV Quality System and provides DSPV Quality Assurance support for SOPs, auditing, deviations, training and CAPAs.
Maintains the DSPV Training Program that expands to applicable functions both internal and external.
Identifies relevant quality-related training needs and conducts training as required.
Monitors adherence and compliance with department documented procedures.
Monitors monthly department SOP compliance
Monitors monthly safety vendor training compliance
Develops and maintains the Sage pharmacovigilance agreement template (PVA)
Works directly with Sage PV partners to develop, finalize and revise PVAs, as needed.
Collaborates with Sage business owners and legal to ensure contracts with external parties contain the appropriate safety language to ensure complete and timely reporting of safety information to DSPV.
Negotiates with internal and external stakeholders as needed to ensure the external party template is aligned with Sage standards.
Creates and maintains the Sage PV templates
Maintains the DSPV Agreement Tracking Tool
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 in life sciences, pharmacy, nursing or equivalent health experience, advanced Life Sciences Degree or MBA preferred
Minimum of 5-7 years of experience in Pharmacovigilance; previous managerial role in drug safety
Demonstrated ability to create, evaluate, and maintain effective business processes and implement procedures, systems, and tools to maximize resources within a Drug Safety department
Thorough knowledge and experience with quality systems
Prior pharmaceutical or biotechnology drug development experience
Comprehensive knowledge of the US FDA regulations and the international pharmacovigilance regulations and requirements, including European Medicines Agency (EMA) Good Pharmacovigilance Practices (GPV)
Excellent oral and written communication skills
Strong interpersonal and leadership skills and demonstrated ability to manage, motivate and influence work behaviors of individuals who are not direct reports
Desire to embrace the Sage core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun
Demonstrates excitement about the culture, vision and mission of Sage
Number of Openings:
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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.
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