Director/Senior Director of Quality Assurance at Neon Therapeutics
Cambridge, MA, US
Position Summary

The Director/Senior Director of Quality Assurance is responsible for leading and strategically directing the Quality organization and is accountable for the continuous development, execution and administration of a GxP Quality System meeting all compliance requirements with respect to Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP), ICH and EMA regulations.

The Director/Senior Director of Quality Assurance will develop, maintain, and continually improve Quality Operations, the Quality Management System, the Quality Assurance program, and the Training Program, as well as provide overall Quality and Compliance oversight for the manufacturing and supply chain process support Neon’s personalized medicines.

Job Duties

Work in a cross-functional environment to develop personalized products to treat cancer.
Represent Quality Assurance in company project meetings to ensure adherence to regulatory and compliance requirements.
Recommend solutions to complex quality issues and work closely with senior management to resolve significant compliance trends and issues.
Develop and implement processes, procedures, and systems to perform critical activities in an efficient and effective manner to assure compliance with applicable regulations and company standards.
Manage audit program against GxP standards, FDA/EMA/ICH requirements, and other regulatory standards and ensure timely resolution of any identified issues.
Implement GCP Quality Assurance programs for clinical trials execution and reporting.
Quality management of CMOs, contract test laboratories and other vendor services to ensure compliance of manufacture and testing of product.
Establish and maintain phase appropriate GMP compliance for product manufacture, testing, and stability; ensure appropriate review and assessment of production records, in-process and release testing methods, specifications, validations, reference materials and test results.
Manage Quality Assurance relationships with GMP service providers; work with CMO QA and technical teams to assess and resolve discrepancies, and noncompliance events to ensure the quality of the product through performance of thorough investigations and risk assessments.
Review and edit Quality Agreements, provide quality input to project plans, master service agreements and statements of work.
Review technical and study reports, CMC sections of regulatory submissions, pharmacy manuals, investigator brochures, study protocols and reports, as requested, for compliance with established standards, and regulations.
Ensure robust planning and execution of documentation for product release.
Manage Training Program.

Experience and essential skills:

Bachelor’s degree, Master’s degree or PhD in science, pharmaceutical sciences or related field
Minimum 15 years of experience in Quality Assurance with at least 10 years of experience in GMP pharmaceutical development, manufacturing and testing
Proven track record of critical thinking, agility. This includes the ability to manage priorities, track progress of key projects, and provide updates to leadership as required.
Thorough knowledge of Phase 1 through Phase 3 product development. Commercial and/or large pharma experience a plus. Technical knowledge of analytical method qualification, process validation and establishing product specifications
Preferred experience with personalized medicines and/or gene therapy
Preferred experience with outsourced manufacturing and testing operations
Experience in working in compliance with US, EU and ICH GMP requirements, experience reviewing submission documentation, responses to regulatory inquiries and inspections
Demonstrated ability to work independently, handle multiple tasks simultaneously, prioritize, negotiate and meet critical timelines.
Excellent oral and written communication.
Strong interpersonal skills to effectively communicate with teams, peers, management and external contacts.
Proven organizational and leadership skills to mentor and develop team to achieve Company goals. Demonstrated ability to effectively lead professional staff
Working knowledge of MS Office products including Word, Excel, Outlook, PowerPoint, and Project.
Must possess excellent organizational and communication skills.

To apply, please send your resume . In the subject line please note the position for which you are applying.