The Director/Senior Director of Quality Assurance is responsible for the strategy, implementation and leadership of the Quality organization at Translate Bio and is accountable for the continuous development, execution and administration of a comprehensive GxP Quality System meeting all compliance requirements pertaining 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 establish, 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 process development, manufacturing and nonclinical, clinical and commercial processes and supply chains.
Establish phase appropriate Quality Systems to support Translate Bio’s growth as a fully integrated emerging biotechnology organization.
Establish and maintain phase appropriate GMP compliance for product manufacturing, testing, and stability; ensure appropriate review and assessment of production records, in-process and release testing methods, specifications, validations, reference materials and test results.
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.
Implement GCP Quality Assurance programs for clinical trials execution and reporting.
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.
Manage audit program against GxP standards, FDA/EMA/ICH requirements, and other regulatory standards and ensure timely resolution of any identified issues.
Quality management of CMOs, CROs, contract test laboratories and other vendor services to ensure compliance of manufacture and testing of Translate products.
Ensure robust planning and execution of documentation for all regulated work and Regulatory submission-supporting activities, both internal and external (CRO, CMO).
Review and edit Quality Agreements, contracts, supply agreements, etc., provide quality input to project/program plans, master service agreements and statements of work.
Review technical and study reports, regulatory submissions, pharmacy manuals, investigator brochures, study protocols and reports, as requested, for compliance with established standards and regulations.
Establish and manage a comprehensive internal compliance training program.
Work cross functionally, representing the Quality group on discovery and development teams, line functions and to senior management for awareness of and compliance with quality/regulatory requirements.
Develop solutions to complex quality issues and work closely with senior management to prevent and resolve significant compliance issues.
Proven track record of creating, establishing and maintaining strategically focused Quality functions.
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, flexibility, innovation, including the ability to manage priorities, track progress of key projects, and provide updates to leadership as required.
Thorough knowledge of Preclinical, Clinical and Commercial product development. Post-market experience a plus. Technical knowledge of analytical method qualification, process validation and establishing product specifications
Preferred experience with personalized medicines and nucleic acid-based and/or gene therapies
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.
About Translate Bio
Translate Bio is a leading biotechnology company focused on pioneering the translation of RNA science into therapeutics promoting healthy gene expression in people living with debilitating genetic diseases. The company’s RNA platforms for powering endogenous therapeutic protein production is applicable to a broad range of diseases caused by insufficient protein production, including rare diseases of the liver, lung and central nervous system.