General Scope and Summary
Sage Therapeutics is searching for an experienced Manager of (DSPV) Quality, Compliance and Training that is a creative, resourceful and integrative thinker. The manager will assist with the establishment and maintenance of the Global Quality System for DSPV that supports Sage products in compliance with 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 and Quality Systems and Medical Affairs.
Roles and Responsibilities
- Develops and maintains policies and procedures for the DSPV Quality System and provides DSPV Quality Assurance support for SOPs, auditing, deviations, training and CAPAs.
- Leads inspection readiness with the Senior Director of PV Operations and coordinates global inspection readiness activities for PV inspections of global products.
- Monitors the global DSPV Quality System through metrics and reports.
- Establish monitoring systems to verify compliance and generate metrics for senior management.
- Establish procedures for documentation of department compliance and the development of quality assurance plans to improve or maintain data quality.
- Collaborate with appropriate stakeholders to establish an inspection readiness process for pharmacovigilance and oversee ongoing readiness activities.
- Monitor adherence and compliance with department documented procedures.
- Monitoring compliance with worldwide regulations for the reporting of adverse events.
- Monitor activities of CROs/business partners to ensure adherence and compliance with applicable SMPs, PVAs and other contractual agreements.
- Develop a DSPV Training Program.
- Identify relevant quality-related training needs and conduct training as required.
- Collaborate with management to evaluate the department’s performance through review of quality reports and compliance metrics and identify solutions for improvement.
- Assist with audit responses from Pharmacovigilance and external partners/vendors and evaluate proposed corrections, corrective actions, and/or preventative actions for compliance with applicable regulations, guidelines, and Sage policies.
- Participates in DSPV audits of vendors and third parties in global territories and provides oversight for consultants conducting audits on behalf of the Company.
Experience, Education and Specialized Knowledge and Skills
- Bachelor’s degree in relevant field (e.g. Life sciences) or equivalent combination of education and experience.
- 3-5 years’ experience in Pharmacovigilance compliance preferred.
- Master’s degree preferred.
- Significant prior pharmaceutical or biotechnology drug development experience
- Comprehensive knowledge of the international pharmacovigilance regulations and requirements, including European Medicines Agency (EMA) Good Pharmacovigilance Practices (GPV)
- Prior experience managing quality and compliance activities
- Excellent problem solving and analysis skills; ability to see trends and convert information to insights.
- Ability to adapt precedent and develop creative and effective solutions to solve problems.
- Must have experience in working with Pharmacovigilance and/or Pharmacovigilance processes.
- 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