We are a leading mRNA therapeutics company developing a new class of potentially transformative medicines to treat diseases caused by protein or gene dysfunction. Using our proprietary mRNA therapeutic platform (MRTTM), we create mRNA that encodes functional proteins. Our mRNA is delivered to the target cell where the cell’s own machinery recognizes it and translates it, restoring or augmenting protein function to treat or prevent disease.
The Quality Documentation Specialist is responsible for helping manage our Quality Management System and overseeing GxP documentation for Translate Bio, our contract organization resources, and our pharmaceutical/biotech partners. This person will participate in ensuring proper Quality and Compliance oversight for process development, manufacturing and nonclinical, clinical and commercial processes and supply chains.
Participate in establishing phase appropriate Quality Systems to support Translate Bio’s growth into a fully integrated commercial biotechnology organization.
Help maintain phase-appropriate cGMP 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.
Ensure that Translate Bio’s Quality documentation meets standards expected by US and global regulatory authorities for research, development and ultimately commercial activities.
Ensure products manufactured at CDMOs meet company quality documentation standards and government regulations.
Establish strong working relationships with external manufacturers of our products and assure alignment of our Quality Systems and requirements with these CDMOs. 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.
Identify and Communicate significant quality risks that may impact product suitability or regulatory compliance in a timely manner to the Director of Quality.
Continually establish and improve quality systems, initiatives, priorities and timelines.
Document archives and help manage the document archival process.
Help manage supplier/vendor qualification audit and inspection management in compliance with applicable GxP standards, FDA/EMA/ICH requirements, and other regulatory standards.
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 documentation compliance with established standards and regulations.
Help establish and manage a comprehensive internal compliance training program.
Participate in the screening and hiring of a Quality staff that includes quality assurance and eventually quality control individuals in a manner consistent with Translate Bio’s core values and commitment to culture
Required Skills & Qualifications
Minimum of Bachelor’s degree in science, pharmaceutical sciences or related field
Minimum 5 years of experience in Quality Assurance with experience in GxP Quality supporting 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.
Preferred experience with outsourced manufacturing and testing operations
Preferred experience in working in compliance with US, EU and ICH GMP requirements, experience reviewing submission documentation, responses to regulatory inquiries and inspections
Preferred experience with personalized medicines and nucleic acid-based and/or gene therapies
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.
Translate Bio is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.
About Translate Bio
We are a leading mRNA therapeutics company developing a new class of potentially transformative medicines to treat diseases caused by protein or gene dysfunction. Using our proprietary mRNA therapeutic platform (MRT), we create mRNA that encodes functional proteins. Our mRNA is delivered to the target cell where the cell’s own machinery recognizes it and translates it, restoring or augmenting protein function to treat or prevent disease.