Associate Director, GxP Operations Support Lab Systems
Vertex Pharmaceuticals, Boston, MA, Onsite
Research DevelopmentBachelor RequiredExecutive Director
About the role
General Summary:
The Associate Director, GxP Operations Support Lab Systems will play a critical role in supporting the laboratory information management systems (LIMS) through ongoing maintenance of implemented features and implementation of new functionality. This position will serve as the Business Owner for the LabVantage LIMS across all Vertex modalities. The role also involves supervising a team both directly and indirectly.
Key Duties and Responsibilities:
- Lead the implementation, optimization, and master data management of LIMS
- Support digital strategies enabling real-time execution, electronic workflow orchestration, automated data collection, equipment/system integration, analytics and reporting
- Oversee technical review of analytical and manufacturing data and documentation
- Manage and own deviation, CAPA, Effectiveness Check (EC), and Change Control (CC) records in the electronic Quality Management System (eQMS)
- Facilitate and lead improvements to LIMS documentation, procedures, processes, and training to enhance efficiency and ensure best practices
- Conduct and supervise LIMS training ensuring consistent and effective execution
- Develop and monitor Key Process Indicators (KPIs) related to the LIMS system
- Mentor, motivate, and evaluate the performance of team members, establishing performance objectives aligned with company goals
Knowledge and Skills:
- Proficiency with Microsoft Office Suite
- Strong organizational skills with the ability to balance changing priorities
- Effective verbal and written communication skills
- Detail-oriented with a focus on accuracy and timeliness
- Ability to learn and adapt to new computer-based systems
Education and Experience:
- Bachelor’s degree or equivalent combination of education and experience in a pharmaceutical or biotechnology manufacturing or quality control environment
- Minimum of 8 years of experience in a GMP pharmaceutical/biopharmaceutical industry
- Proven experience in implementing and managing LIMS, particularly LabVantage
- Direct oversight or management of personnel
About Vertex Pharmaceuticals
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and has made significant advancements in cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia, and acute pain — and continues to progress clinical and research programs in these diseases. We also have a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where we have deep insight into causal human biology, including acute and neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes and myotonic dystrophy type 1. Our global headquarters is in Boston, and we have research and development (R&D) sites and commercial offices worldwide. Vertex is consistently recognized as one of the industry’s top places to work by Science Magazine, The Boston Globe, Boston Business Journal and the San Diego Business Journal. We have also earned a spot on TIME Most Influential Companies, TIME Best Inventions, and Fast Company Most Innovative Companies lists. Our research and medicines have received esteemed recognitions, including the Robert J. Beall Therapeutics Development Award, the Prix Galien, the Scrip Award and the Breakthrough Prize awards. Read our community guidelines: https://www.vrtx.com/vertexs-community-guidelines/