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Job Description

General Summary:

The Director, GxP SOPs and Training - Process Excellence, will be a key contributor in the GxP Process Operation Center (GPOC) and have overall responsibility for driving improvements to processes, systems, and governance around GxP procedures and training/education.

This role is primarily responsible for transforming GxP documentation and training process capabilities, including their effectiveness and efficiency, reliability, ownership, and scalability. This includes engaging with Quality process and system owners to continually improve GxP Documentation and Training-related processes, tools, and systems used across the enterprise.

This individual will also engage with all GxP functional areas on cross-functional improvements related to GxP Documentation and Training.

Activities include, but are not limited to, defining and implementing cross-functional improvement targets, roles and responsibilities, enterprise-level standards and solutions, and sustainment models. Ability to formulate and execute change strategy, lead cross-functional teams and drive decisions, as well as to effectively lead/collaborate with cross-functional business stakeholders for value-added impact, will be key to success in this role.

The individual in this role will also be responsible for the overall business ownership of our Veeva Quality Environment that’s supports our Quality Management System and Document Management system

The Director will also assume the responsibility as the Process Owner for the QMS Event& Capa process. Driving long term strategy and process optimization to make sure the Event & Capa process supports Vertex' continuous growth ambitions.

Key Duties and Responsibilities:

• Provides direction to continually improve processes governing GxP controlled documents (e.g. Standard Operating Procedures, Work Instructions) and GxP training curriculums/courses
• Partners across Quality and business stakeholders/leaders across GxP areas to advance process ownership, governance, systems, and processes that are fit-for-purpose, effective and sustainable
• Establishes continuous improvement roadmap, defines and tracks improvement targets, and drives cross-functional transformations in line with strategic Quality roadmap
• Drives a culture of continuous improvement across documentation, training programs, and related initiatives
• Partner with QMS and DMS process owners to evaluate and decide on system improvements and upgrades to improve overall user experience and increased system use.
• Business Owner of the Veeva Quality Doc environment (QMS and DMS ) - Driving & Supporting continuous optimization of our Veeva solution.
• Provides strategic vision and process improvements for the Event and Capa process that support Vertex' ambition.

Knowledge and Skills:

• Demonstrated strategic planning and execution skills
• Creative, innovative leadership experience complemented with strong change management experience, adaptability, resourcefulness
• Excellent communication skills and proven track record building/promoting continuous improvement mindset
• Operational Excellence experience with proven ability to lead improvement projects
• Strong problem solving and critical thinking skills, accompanied by Analytical thinking/Data Analysis skills
• Experience with Event& Capa process, either as a process owner or regular participant in or stakeholder of the process
• Experience with Veeva Quality Suite (QMS/DMS) as a business owner.

Education and Experience:

• Bachelor's degree in a scientific or allied health field (or equivalent degree)
• Typically requires 10+ years of relevant experience and 2 years of supervisor/management experience, or the equivalent combination of education and experience

#LI-SV1 #LI-Hybrid

Flex Designation:

Flex Eligibility Status:

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