The Associate Director of GMP Operational Quality Assurance is an advanced technical resource and is recognized as an expert internally in the principles and application of quality and regulatory compliance. The individual adapts to new and multiple projects, effectively ensuring alignment with corporate goals and compliance with all regulatory requirements. The Associate Director of Quality Assurance is responsible for oversight of multiple Validation projects associated with Product Launch and Continuous Improvements, ensuring effective alignment with business timelines and compliance with relevant global regulatory requirements. This role is expected to work closely with business partners and stakeholders to ensure successful project execution for Finished Goods (FG) commercialized globally. The role is responsible for coordinating and/or executing Validation activities on multiple complex projects and ensures process robustness from initial design through ongoing product supply and continuous improvements. This position reports directly to the Director of GMP Operational Quality.
Key Responsibilities:
Minimum qualifications:
Master's degree and 5-8 years of relevant work experience, or Bachelor's degree in a scientific or allied health field (or equivalent degree) and 9+ years of relevant work experience, or relevant comparable background.
Pay Range:
$159,800 - $239,800
At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.
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.
GMP Operational Quality Packaging & Labeling Validation Associate Director • Boston, MA, United States
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