5597 - Veeva Quality Process Owner / Senior Business Architect

Description

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise
  
  

Overview

We are seeking a skilled Senior Business Architect with expertise in Veeva Quality to join our team. The successful candidate will be responsible for and possess the following qualifications:

Job Responsibilities

• Defining Product Vision: Establishing and maintaining a clear vision for the product, ensuring it aligns with business goals and customer need
• Quality Systems: Knowledge of Quality Systems in Life sciences is required
• Managing Product Backlog: Prioritizing and maintaining the product backlog, ensuring that the most valuable features are developed first
• Stakeholder Collaboration: Working closely with stakeholders to gather requirements, understand their needs, and incorporate their feedback into the product development process
• Overseeing Development Stages: Guiding the product through various stages of development, from initial concept to final release
• Developing User Stories: Serves as liaison between GPO and SMEs to translate business needs/requirements to actionable and testable user stories
• Setting Acceptance Criteria: Defining clear acceptance criteria for each feature to ensure the development team understands what needs to be built
• Monitoring Progress: Tracking the progress of the product development, ensuring that it stays on schedule and meets quality standards
• Participating in Scrum Meetings: Engaging in Scrum meetings and product sprints to provide updates, address issues, and ensure alignment with the product vision 1
• Documentation: Publishing and presenting user requirement/system reports and documentation
• Develop data strategy: Create a strategy that supports the organization's current and future needs
  
  

Required Qualifications

• Education: Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field
• Experience:
• Minimum of 10 years of experience in Computer System Validation (CSV) within a regulated industry (pharmaceutical, biotech, or medical device preferred)
• Hands-on previous experience implementing Veeva Systems
• Technical Skills:
• Strong understanding of GAMP 5 methodology and FDA 21 CFR Part 11 compliance
• Proficiency in developing and executing IQ/OQ/PQ protocols
• Familiarity with laboratory workflows and integration of Empower with analytical instruments (e.g., HPLC, GC)
• Knowledge of change control, deviation management, and CAPA processes
• Understanding of data integrity principles and their application to QMS systems
• Soft Skills:
• Excellent written and verbal communication skills for documentation and training purposes
• Detail-oriented with strong organizational and problem-solving abilities
• Ability to work independently and collaboratively in a team environment
  

Additional Requirements

• This is a remote role.
  
  

For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.

• Verista is an equal opportunity employer.
  
  

National (US) Range

$102,410—$168,011 USD

Benefits

Why Choose Verista?

• High growth potential and fast-paced organization with a people-focused culture
• Competitive pay plus performance-based incentive programs
• Company-paid Life, Short-Term, and Long-Term Disability Insurance.
• Medical, Dental & Vision insurances
• FSA, DCARE, Commuter Benefits
• Supplemental Life, Hospital, Critical Illness and Legal Insurance
• Health Savings Account
• 401(k) Retirement Plan (Employer Matching benefit)
• Paid Time Off (Rollover Option) and Holidays
• As Needed Sick Time
• Tuition Reimbursement
• Team Social Activities (We have fun!)
• Employee Recognition
• Employee Referral Program
• Paid Parental Leave and Bereavement
  
  

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For more information about our company, please visit us at Verista.com