QA Associate Director, CMC Regulatory Submission QC and Audit
 Vertex Pharmaceuticals Incorporated | |
paid time off, 401(k)
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 United States, Massachusetts, Boston | |
| 50 Northern Avenue (Show on map) | |
 Mar 05, 2025 | |
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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:
Knowledge and Skills:
Education and Experience:
#LI-LN1 Pay Range: $147,600 - $221,300Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site EligibleFlex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 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 | |