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

myGwork - LGBTQ+ Business Community; Boston (MA); Hybrid; USD 148,000 - 224,000; Full time

Job summary

A leading biotechnology company is seeking an Associate Director for QMS and Process Excellence to drive improvements in quality management systems. This role involves overseeing the Event and CAPA processes, ensuring compliance, and collaborating across various departments to optimize performance. Candidates should have significant experience in QMS management, along with a strong educational background in relevant fields.

Benefits

Generous paid time off

Educational assistance programs

401(k) matching

Commuting subsidy

Qualifications

• Requires 8+ years of relevant QMS management experience within pharmaceuticals or biotech.
• Experience with electronic quality management systems (e.g., Veeva required).
• Proven ability with continuous improvement using methodologies like Six Sigma.

Responsibilities

• Lead GxP Quality Event (Deviation) and CAPA processes, managing improvements and governance.
• Develop strategic vision for Event and CAPA Quality Management System.
• Oversee the enhancement of quality systems and process optimization.

Skills

Problem solving

Data Analysis

Critical thinking

Education

M.S. (or equivalent)

B.S. in a scientific or allied health field

Tools

Veeva Vault

Job description

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

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

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This job is with Vertex Pharmaceuticals, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

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
  
  

Pay Range

$148,800 - $223,200

Disclosure 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 Eligible

Flex Eligibility Status

In this Hybrid-Eligible role, you can choose to be designated as:

• Hybrid: work remotely up to two days per week; or select
• 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 [e-mail]

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Management and Manufacturing

• Industries

  Biotechnology

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