Principal Rems Quality Specialist

**Description**

**JOB SUMMARY**

The Principal REMS Quality Specialist will perform audits remotely or onsite to ensure stakeholders (pharmacies, healthcare providers, wholesaler-distributors) are compliant with the REMS (Risk Evaluation Mitigation Strategy). The audits will determine if the elements to ensure safe use of a drug product is being carried out by the stakeholder.

**JOB RESPONSIBILITIES**
- Perform questionnaire and/or on-site audits of stakeholders (pharmacies, healthcare providers, wholesaler-distributors) enrolled in a Risk Evaluation Mitigation Strategy (REMS) Program
- Review audit responses and audit supporting documentation and generate audit reports.
- Assign finding criticality according to the approved audit plan
- Support End-to-End Corrective and Preventive Action (CAPA) management systems implementation
- Track CAPAs through to completion, including updates to senior management and escalations as required
- Assist in follow-up of open and overdue CAPAs with stakeholders to ensure accuracy and quality of data
- Provide updates to clients on audit outcomes
- Provide requested information when needed to support REMS Assessment reports
- Perform gap analysis of Quality systems and procedures and provide insights and feedback on continuous improvement areas
- Research the GxP standards, regulatory authority websites
- Serves as a Project Manager on different programs including but not limited to monitoring of other team members performance, evaluation of the KPIs and implementation of measures to solve any detected gaps
- Provides training and consultancy on quality and regulatory related issues
- Active in appropriate industry associations, community bodies, and other relevant forums to help promote Company in drug development community
- Performs other work-related duties as assigned

**QUALIFICATION REQUIREMENTS**
- BA/BS degree in the science/health care field or equivalent combined education and experience. Three (3) to five (5) years’ Pharmaceutical or Healthcare related industry experience.
- Understanding and expertise in international requirements for Good Clinical Practice (GCP) and/or Good Manufacturing Practices (GMP).
- Experience leading quality audits and managing corrective and preventive actions.
- Experience with REMS auditing preferred.
- Well-developed communication skills and the ability to write and present concise, accurate documentation.
- Demonstrated leadership skills preferred.
- Ability to handle multiple tasks to meet deadlines in a dynamic environment.
- Strong organizational, presentation, documentation and interpersonal skills with diverse cultures.
- Ability to negotiate and provide constructive feedback.
- Ability to work as part of a team, as well as independently.

**Why Syneos Health?** Here, you’re a part of the big picture. You will collaborate with colleagues across clinical and commercial disciplines to guide premarket development through post-market commercial strategy. Every project is a chance to solve a new challenge, learn from your colleagues, and advance your career. The diversification and breadth of our new and existing partnerships create a multitude of career paths and employment opportunities. Join our game-changing, global company dedicated to creating better, smarter, faster ways to get biopharmaceutical therapies to patients. Experience the thrill of knowing that your everyday efforts are contributing to improving patients’ lives around the world.

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- Syneos Health companies are affirmative action/equal opportunity employers (Minorities/Females/Veterans/Disabled)_