Overview

Work at ROCKET PHARMA and help cure rare diseases!

Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline. We are looking for hands-on team players who enjoy collaborating with colleagues. We share a passion for seeking gene therapy cures for devastating diseases and making a difference for patients. This is an opportunity to become an integral part of a small, highly productive team and to help grow an entrepreneurial, scientifically driven organization that is increasingly recognized as a leading biotechnology innovator. In addition to a competitive compensation package featuring a generous 401K match and stock options, the position includes excellent health benefits.

Position Summary

The Senior Manager, Quality Management Systems (QMS) role involves the management and oversight of the core quality systems, including but not limited to various investigations management, CAPAs, change management, document management, risk management, compiling, trending QMS and reporting key quality metrics for periodic management review, and other quality system functions, as needed. Support entire GxP Quality Management systems encompassing all GxP functional departments (GMP, GLP, GCP, GVP, GDP as appropriate) to ensure compliance with applicable regulations and Rocket procedures. This position reports to the Director, QMS.

Responsibilities

• Responsible for lifecycle management of policies and procedures in the GxP Quality Management System (QMS) Framework, including providing support with document authoring, approval, issuance, training, implementation, periodic review, and retirement.
• Owner of key QMS procedures and workflows such as Change Controls, Deviations, and CAPAs.
• Perform trending of various QMS events from Rocket’s electronic QMS system including but not limited to deviations, CAPAs, OOS investigations, and change controls as necessary to identify trends or areas requiring additional actions.
• Manage and ensure that the QMS electronic platform remains in a validated state.
• Responsible for document management for GxP records generated internally and externally.
• Provide quarterly metrics for Quality Management reviews and track any associated actions.
• Contribute and support ongoing improvement efforts at Rocket within quality systems and maintain quality systems to ensure compliance with applicable local and global regulations while meeting Rocket’s business requirements.
• Maintain a contemporary knowledge of current industry trends, regulations, standards, health authority guidelines and methodologies as it relates to quality systems and regulatory compliance.
• Provide support during health authority inspections, internal audits, and other external audits.
• Responsible for and administers the Risk management system (i.e. risk register) and track completion of risk assessments. 
• Supporting other Quality Assurance tasks, as required.

Qualifications

• Bachelor’s degree in a life sciences discipline.
• 10 years of biologics, cell gene therapy, or pharmaceutical industry experience industry experience with diverse quality and/or compliance discipline.
• Demonstrated knowledge in quality and/or compliance discipline within depth knowledge of Quality Systems across different GxP areas and global health authority regulations.
• Ability to manage high volume works with competing priorities.
• Strong negotiating and influencing skills in a matrixed organization.
• Critical thinking skills in analyzing and exercising judgment on complex issues, guided by a thorough understanding of quality philosophy.
• Proficient in MS Office and Collaboration applications.
• Experience with electronic QMS systems (e.g. ZenQMS, Veeva, TrackWise, etc.) and documentation management systems.
• Excellent technical writing skills.
• Strong verbal and written communication skills.
• Project management skills preferred.
• 10% travel may be required.

EEO Statement

A diverse workforce fosters innovation and strengthens Rocket’s business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.