Senior Consultant, Validation

Description

Dot Compliance is a leading provider of cloud-based Quality and Compliance management solutions for the life science industry. Built on the world’s most innovative cloud platform, Salesforce, Dot’s SaaS solutions are transforming how pharmaceutical, biotech, and medical device companies manage quality and compliance in regulated processes. We are a dynamic, growing company looking to make a significant impact in the industry.

Our ideal candidate should be passionate about applying their validation expertise in a modern SaaS setting to influence strategy, build client trust, and grow professionally. You will succeed in this role if you are a detail-oriented advisor who thrives in a fast-paced, collaborative environment.

Responsibilities:

• Work closely with customers to implement our Quality Management solutions and maximize the use of features in alignment with customer requirements.  
• Develop and direct work plans, schedules, project estimates, and resource plans. 
• Communicate best practices to help guide customers during the implementation process. 
• Collaborate with customers and IT teams to support integration with other applications. 
• Provide training, coaching and mentorship to help customer stakeholders develop their quality management system knowledge. 
• Lead the planning, development, and execution of validation deliverables (e.g., Validation Plans, Requirements Specifications, Test Scripts, Traceability Matrices, Summary Reports) for client implementations. 
• Partner with clients to define validation scope and approach aligned with regulatory requirements and frameworks (e.g., FDA 21 CFR Part 11, Annex 11, GxPs, GAMP 5). 
• Guide cross-functional teams to ensure validation activities are delivered on time and within project scope. 
• Serve as the primary point of contact for validation and compliance questions during client implementations. 
• Develop and maintain validation templates, processes, and best practices for Professional Services engagements. 
• Train and mentor internal team members and client stakeholders on validation processes and regulatory expectations. 
• Identify opportunities for continuous improvement in validation methodologies and execution efficiency. 

Requirements

Requirements:

• Bachelor’s degree in Computer Science, Life Sciences, Engineering, or related field. 
• 7+ years of experience in Computer System Validation (CSV), Quality, or Compliance roles, ideally within SaaS or cloud-based solutions. 
• Strong knowledge of regulatory requirements (FDA 21 CFR Part 11, Annex 11, GxPs) and industry frameworks (GAMP 5). 
• Proven track record leading validation efforts for enterprise software or SaaS implementations. 
• Experience with Professional Services or consulting engagements. 
• Excellent communication, client-facing, and project leadership skills. 
• Ability to manage multiple client projects simultaneously in a fast-paced environment. 
• Familiarity with risk-based validation and modern approaches to cloud/SaaS compliance. 

A+ If You Meet These Requirements

None