QA Associate Director, CMC Regulatory Submission QC and Audit

Vertex Pharmaceuticals Incorporated
United States, Massachusetts, Boston
50 Northern Avenue (Show on map)
Jan 18, 2025
Job Description The QA Associate Director, CMC Regulatory Submission QC and Audit, is responsible for the audit/review of all regulatory submissions in support of submission readiness for small molecule, biologics, and medical devices. This position will be responsible for auditing/reviewing regulatory submissions, working closely with the Regulatory Affairs, Quality Assurance, Operational QA, and business stakeholders to ensure the quality and on-time delivery of our regulatory submissions to support global expansion efforts, scale-up and post approval changes. This role will manage and maintain submission audits, ensuring that plans are in place, and that activities are completed to support submission timing and expectations. It is also responsible for the development and maintenance of GMP Certificates and Declarations, and other compliance documentation required for submissions. This is a hybrid role based out of the Boston office (3 days onsite/2 days flexible). Key Duties and Responsibilities: Engages with relevant stakeholders to develop a holistic Quality strategy for regulatory submission audits Serves as process owner and provides oversight of the submission audits (IND/NDA and international equivalents) and supports global expansion efforts, scale-up and post approval changes Ensures robustness of submission audit process including implementation of improvements and establishment of metrics Develops, maintains, and executes strategic Audit Plans to support Regulatory Submission audits (GMP/GDP/ Biologics/ Medical Devices) Partners with key stakeholders for coordination and alignment in ensuring overall quality of audit and adequacy in remediation/improvement Compare source data (e.g., certificates of analysis, batch records, comparative analysis reports, stability reports, etc.) with submission data Represent QA and Compliance at all submission related kick-off meetings & raise any risks & provide any necessary direction Attend submission review meetings to support filings, responses to health authority filing inquiries and review submission content for accuracy Support all compliance document requirements for submissions (e.g., Certificates, Declarations, Powers of Attorney, and other local legally required documents) Participates in collaborative review of impacted SOPs/WIs Escalates critical and major findings/issues to Quality management Develops, reviews, and analyzes Key Performance Indicator data and trends related to regulatory submissions audits for GMP/GDP/ Biologics/ Medical Devices Drive process improvement initiatives related to regulatory submission data integrity audits May engage in preparation, support, and follow-up activities for regulatory inspections Support other activities, projects, etc. related to the Inspection Readiness team as necessary Knowledge and Skills: QA audit experience / data review and verification In-depth knowledge in the following areas: Regulatory Submission requirements (INDs//NDAs/SNDAs and international equivalents) Regulatory Submission Data Review GMP/GDP/ Biologics/ Medical Devices Audit processes GMP/GDP/ Biologics/ Medical Devices Quality Systems Global GMP regulations (US/EU etc.); 21 CFR Part 210/211, ICH guidelines and international equivalents as necessary Global Biologics regulations (US/ EU, etc.); 21CFR Part 600/ 680, ICH guidelines and international equivalents as necessary Global Medical Device regulations (US/ EU, etc.); 21CFR Part 810/ 820, ISO 13485, ICH guidelines and international equivalents as necessary CMC Documentation (e.g., NDA Submissions.) Project management experience Ability to work autonomously with minimal oversight and with urgency to support filing timelines Experience and ability to participate on cross-functional teams, be extremely collaborative and flexible Excellent communication skills and a proven track record influencing/ building/ promoting a culture of continuous improvement General global experience in life sciences, Quality Operations and Regulatory Education and Experience: M.S. (or equivalent degree) and 5-8 years of relevant work experience, or B.S. in a scientific or allied health field and 10+ years of relevant work experience, or relevant comparable background #LI-LN1 Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com