Sr. Director/ Vp, Quality Assurance

Sr. Director/ VP, Quality Assurance

Rapport Therapeutics, a well-funded Third Rock start up with sites in Boston and San Diego is seeking a talented VP of Quality to serve as an internal expert and build this function in our company. Reporting to the CDO, the incumbent will be required to work flexibly across a number of small molecule drug development programs with responsibilities for all aspects of Quality Assurance. The Sr. Dir/VP of Quality Assurance is responsible for leading and managing all Rapport Therapeutics Quality Assurance (QA) programs, activities, and staff to ensure compliance with global laws, regulations and applicable guidance. The overall responsibility of this role is to design and execute strategic and tactical guidance for GxP (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)) compliance for manufacturing, distribution, test laboratories and clinical trial activities. In addition, this role will have QA oversight for Computer System Validation (CSV) activities.

Responsibilities:

• Ensure the QMS has the appropriate level of rigor and controls to ensure compliance with applicable regulations and guidance Create and execute a plan for ensuring a state of inspection readiness and continuous improvement including:
• Ensure rapid escalation of significant quality issues or concerns Ensure the completion of scheduled third-party audits by internal QA staff or external contractors Provide feedback to operational department heads regarding audits, plans, findings, CAPAs, and issue resolution; provide suitable recommendations and facilitate ongoing quality improvements while maintaining compliance
• Ensure the Company is kept current with all new quality-related regulatory requirements, and provide guidance to senior and operational management on the implications of any new or updated requirements
• Ensure that company and departmental SOPs, job descriptions, and training documentation are current, relevant, and appropriately maintained; ensure the development and maintenance of GMP/GLP/GCP
• Design and maintain a fit for purpose quality management system (QMS) across the GxPs by directing and providing oversight and input into the relevant quality systems and standards including but not limited to: change control; documentation systems; quality procedures, standards, and policies; product complaints; quality system reporting; personnel training documentation and other related areas.
• Maintain an inspection-ready environment at all times through a robust, internal self audit program and delivery of audit-readiness functional training o Ensures the follow-up and closure of all corrective and preventive actions (CAPAs) from internal audits, regulatory health authority inspections and notified third-party audits Create a process for identifying, adjudicating and remediating risks and/or compliance concerns/issues.
• Develop, implement, maintain, and communicate the Company's quality strategy and programs Provide leadership and strategic guidance in ensuring continuous compliance with all applicable internal and external regulations, standards, policies, and procedures related to the quality, regulatory status, and performance of Company operations, processes, and products

Qualifications

• Demonstrate excellent leadership and communication skills.
• Experience implementing quality and business process improvement initiatives in a global, discrete manufacturing environment.
• Bachelor's degree Life/Health Sciences; Master's degree and/or Ph.D. a plus Minimum 15 years of leadership experience within a Quality and Product Development Organization 10 years of Quality leadership/management experience in director or higher-level position.
• Experience in overseeing or participating in GCP audits; experience including external CRO, clinical/regulatory and document auditing desirable.
• Advanced knowledge of Quality Assurance principles, concepts, industry practices, and standards
• Extensive experience handling health authority inspections required Small molecule drug development experience highly desirable
• Experience in clinical trials with small molecules a plus Superior team leadership, communication, collaboration, and problem
• Experience with documentation systems and with document review and auditing. Excellent communication skills, team members that can work collaboratively with colleagues across all functions.
• Comprehensive knowledge of current US and ex-US regulatory guidelines, required.
• Experience in all phases of regulatory submissions and interactions; international experience desired. Experience with database management abilities.
• Prefer hands-on experience implementing Quality initiatives in manufacturing, field service, and transactional areas.
• Strong analytical and problem-solving skills possessing proven record on quality tools.
• Excellent analytical, presentation, writing, and computer skills are required.

Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.