Sr. Principal Analyst, Quality Systems

Job Description

The Sr. Principal Analyst Quality Systems plays a key role within the QARA (Quality and Regulatory) Technology function. The role will be a key technical resource overseeing the Quality Batch Disposition system. Primary responsibilities include gathering and refining requirements determining options for solution design supporting integrations maintaining system operations and delivering enhancements.

Key Duties and Responsibilities:

• Serve as the platform owner for an integrated quality batch disposition system. Implement and manage data and technology solutions across Vertex Quality with focus on integrated quality batch disposition system.

• Lead installation configuration and troubleshooting processes for integrated batch disposition

• Conduct data quality assessments data flow and mapping exercises for integration projects and guide integration teams for the execution.

• Ensure data and technology solutions are developed on time within budget and to the required quality standards.

• Implement and test system configuration enhancements for quality applications and platforms.

• Interact with offshore support application development and system support teams to ensure a secure and properly configured application environment to support critical quality batch disposition processes.

• Work closely with DTE Compliance Internal Audit and Quality Assurance groups as needed to ensure compliance with all appropriate regulations as well as our DTE system lifecycle and change management requirement.

• Support digital transformation initiatives such as integrated Quality operations digital AI/ML-driven process optimization and automation and predictive models for improved quality control.

• Evaluate and implement emerging technologies including AI and GenAI to support the overall goals of the Quality function.

Knowledge and Skills:

• In-depth knowledge of the quality batch disposition business processes and experience with automating batch processing know what good looks like!

• Significant experience in delivering and managing technologies to support quality batch disposition is required

• Good knowledge of Veeva Vault Quality is preferred

• Good knowledge of manufacturing systems inventory management systems laboratory information systems and QMS.

• Proficiency in data management automation principles and methodologies.

• Proficiency in rapidly adopting and implementing emerging technology (e.g. AI/ML agentic)

• proven track record of on-time project delivery for large complex projects with global stakeholders

• In-depth and specialized knowledge in the core disciplines of project management business analysis solution design delivery and training

• Exceptional written and verbal communication skills and ability to present in a clear and concise manner to all audiences

• Strong analytical and problem-solving skills

Education and Experience:

• Bachelors degree in technology discipline or equivalent. Advanced degree preferred

• Typically requires 9 years relevant business systems in the Life Sciences industry

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 Vertexs 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 persons 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