Director - Computer Systems Validation

Team: Quality & Security & Compliance - NA

Location: Massachusetts - Boston

Commitment: Full-Time

Workplace Type: remote

The Role

What Youll Do

Manage/mentor a validation team of validation program managers / team leads (direct reports) on validation projects of Veeva and internal business systems to ensure deliverables conform to company and regulatory requirements
Responsible to deliver validation projects under strict deadlines to ensure customer success. Review and approve validation approach, method, and reporting (VPP, VIA, VSR) during periodic releases of Veeva software products
Establish validation processes commensurate with the level of risk and manage the execution of validation projects whose scope, regulatory visibility, schedule requirements, and complexity require coordination with customers, collaborators, and quality
Oversee on-shore and off-shore team of validation contractors testing of Veeva products to ensure deliverables conform to defined budgets and timelines
Act as executive management interface between Product Development, Operations, Security, and Quality Assurance/Compliance regarding Computer Systems validation exigencies and problem resolution
Support planning and execution of product and internal system periodic reviews
Execute other projects/duties as assigned to ensure compliance across Veeva’s product line and internal business systems

Requirements

Knowledge of Software Engineering and Quality Assurance generally attained through studies resulting in a B.S., in engineering/sciences, a related discipline, or its equivalent and applicable industry experience
10+ years of directly relevant experience in validation of enterprise software, computer information systems used in life sciences regulated environment (GMP, GCP, GLP, GvP)
Hands-on experience or working knowledge of risk-based validation, compliance frameworks, and governance for AI/ML-enabled capabilities in life sciences software
Previous managerial experience (5+) which demonstrates proficiency in selection, motivating and retaining a superior team, effectively managing personnel issues and planning and administering financial resources
Demonstrated understanding of ERES regulations (e.g., 21 CFR Part 11, etc.)
Applied experience (i.e., through validation activities, audit support, and/or software system/software product compliance evaluation) in GCPs (e.g., ICH E6, 21 CFR 56, etc.), GMPs (e.g., 21 CRF 211, 21 CFR 820, etc.)
Use and/or development of risk-based, critical thinking decision-making models to inform validation related activities
Excellent project management, communication, and technical writing skills are required
The successful candidate will possess the professionalism and technical competency required to represent the department before our customers, regulatory agencies, and management
Proven ability working in a matrix environment and leading multi-level / cross functional teams to achieve the highest performance in meeting site and departmental objectives

Nice to Have

Exposure to Agile SDLC, SaaS, AI, and/or IT cloud technologies
Awareness of various global standard frameworks such as ISO, SEI, ITIL
Exposure to global Health Authorities (e.g., FDA, EMA, Health Canada, MHRA, etc.) with respect to computer system validation & data integrity
Experience with automated testing technologies

Interviewing with Veeva

We value your time and believe in a transparent hiring process. Here is the process you can expect.
Follow the application process and submit your resume.
If moving to the interview stage, our process is as follows:
1. A conversation with the hiring manager
2. A personality assessment
3. A practical case exercise
4. A final conversation with our groups Senior Leader
Once all interviews are complete, the manager will be in touch with a final decision. 

Perks & Benefits

Medical, dental, vision, and basic life insurance
Flexible PTO and company paid holidays
Retirement programs
1% charitable giving program

Compensation

Base pay: $150,000 - $230,000
The salary range listed here has been provided to comply with local regulations and represents a potential base salary range for this role. Please note that actual salaries may vary within the range above or below, depending on experience and location. We look at compensation for each individual and base our offer on your unique qualifications, experience, and expected contributions. This position may also be eligible for other types of compensation in addition to base salary, such as variable bonus and/or stock bonus.

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