Associate Director, QMS and Process Excellence, Quality Standards, Training and Improvement

Job Description

General position summary:

The Associate Director, QMS Event and CAPA Management - Process Excellence, will be a key contributor in the GxP Process Operation Center (GPOC) and have overall responsibility for driving improvements to the Event and CAPA quality management system including processes, systems, governance and key performance indicators (KPIs).

This role is primarily responsible for Process Ownership for the Event & Capa Management processes but will also support other QMS (Quality Management System) areas. This includes oversight for the end-to-end processes (e.g.) in the design, deployment, oversight and monitoring of the Event and CAPA Global Quality Systems for performance and effectiveness across the operational areas including GxP disciplines, modalities (small molecules, cell/gene therapies, medical devices), technologies and countries/regions globally. This role will be responsible for identifying improvement opportunities to maximize value, impact and delivery in assuring compliance, process optimization and supporting Vertex' continuous growth ambitions.

This position reports directly to the Director, Quality Stnds, Training, & Improvements- Process Excellence.

Key Responsibilities:

The responsibilities of this position may include, but are not limited to, the following:

• Lead the GxP Quality Event (Deviation) and CAPA processes including managing the process improvement, governance (process owner network), and KPIs improvement plan.
• Support the creation of the strategic vision for the Event and CAPA Quality Management System that supports the VX-2030 vision.
• Own and review standard operating procedures, training content and documentation required to advance those changes and initiatives.
• Serve as business owner of the Deviations and CAPA Veeva Vault Quality workflows (eQMS) including enhancement identification and lifecycle management support.
• Use in-depth knowledge of concepts/techniques to optimize procedures, processes and systems to serve as project lead on continuous improvement projects for the GPOC team including Deviations and CAPA Management, Training and Documentation Control.
• Partner cross-functionally with Quality, Clinical, Regulatory, Technical Operations and IT to align process and system changes.
• Oversee Veeva Vault Intake process for enhancement requests to the Veeva eQMS and align request across platform to ensure consistency
• Develop action plans to ensure KPIs are meeting established targets and work with the PON to implement these action plans.

Minimum Qualification & Experience:

• 8+ years of relevant QMS management experience within the pharmaceutical or biotech industry
• Broad regulatory compliance and quality management experience (across multiple GxP areas) with leading knowledge of industry trends and best practices for efficiency, compliance, and effectiveness
• Demonstrated experience in design, management, and improvement of global quality processes including Deviations, CAPA and other quality system processes.
• Operational experience owning investigations for deviations and implementing CAPA/EC plans.
• Experience meeting regulatory expectations and applying applicable regulatory guidance to deviation and CAPA processes.
• Proven ability to design and implement continuous improvement projects with a focus on KPIs improvement and effectiveness with the use of business process improvement methodologies, preferably Six Sigma, RCA Tools and DMAIC Concepts
• Experience with electronic quality management systems (ex: Veeva required)
• Strong problem solving and critical thinking skills, accompanied by Analytical thinking/Data Analysis skills
• Strong verbal and written communication skills with the ability to work in a dynamic team environment, manage priorities, and maintain timelines for multiple projects.
• Broad and deep operational and project management knowledge and experience

Education and Experience:

• M.S. (or equivalent degree) and 8+ years of relevant work experience, or B.S. in a scientific or allied health field (or equivalent degree) and 9+ years of relevant work experience, or relevant comparable background
• Experience supporting Quality Management Systems - specifically Deviations and CAPA Management

#LI-hybrid

Pay Range:

Disclosure Statement:

Flex Designation:

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