Validation SME - Delivery Leader
$150k - $200k+ Performance-based incentive programs
Expert
Bachelor's
United States
HybridMust reside within daily commuting distance of the Boston, New Jersey, or Research Triangle Park markets; travel is approximately 50%.
Biology & BiotechRegulatory & Quality (Life Sciences)
About the job
Requirements
- A bachelor's degree in a technical (STEM) discipline.
- At least 15 years of engineering experience in a GMP-regulated environment, with direct pharmaceutical or medical-device validation experience.
- At least 5 years of professional services and consulting experience.
- At least 5 years of professional-services business development and customer-relations experience.
- Expert knowledge of FDA regulations, ISPE guidelines, and ISO standards, including GAMP 5, Good Documentation Practice in a pharmaceutical environment, ASTM E2500, ISO 14971 risk management for medical devices, ISPE Applied Risk Management for C&Q, ISPE's science- and risk-based approach to facilities, systems, and equipment delivery, and ICH Q8, Q9, and Q10 risk management and risk-analysis tools.
- In-depth knowledge of process, manufacturing, and/or packaging-equipment validation in life sciences or GMP environments.
- CQV and CSV expertise with equipment and associated software systems.
- A holistic understanding of process systems, including work processes, optimization methods, risk management, and project management.
- Experience working in a fast-paced, high-growth, results-driven organization.
- Project-management experience managing numerous projects ranging from $50,000 to more than $5 million.
- Prior supervisory experience managing at least 20 people and at least 3–5 direct reports.
- A background in internal and external CSV and CQV validation.
- A record of being sought out for industry best practices in developing pharmaceutical and biotechnology validation standards and compliance.
- Ability to meet, interact with, and present to customers in roles including C-level executives, project managers, plant engineers, supervisors, and operators.
- Ability to strategically negotiate with clients and employees in high-stress situations to resolve project and technical issues, funding discussions, change orders, and employee-performance matters.
- A history of leadership, practical validation knowledge, and timely project delivery, project management, cost control, and customer satisfaction.
- Ability to provide colleagues with practical, specific guidance on industry guidance and regulatory requirements.
- Intermediate-to-expert proficiency with Microsoft Word, Excel, and Project.
- Excellent written and verbal English communication skills.
- Ability to guide a team through stressful, client-service-oriented projects.
- Understanding of laboratory, automation, manufacturing, and assembly equipment, including PLCs, HMIs, and PC-based controls.
- Understanding of enterprise-level systems commonly used in pharmaceutical and biotechnology companies.
- High proficiency in authoring, editing, and executing validation documents for equipment, facilities, and utilities.
- Ability to work at client sites and travel regularly; typical travel is approximately 50%.
- Ability to reside within daily commuting distance of the East Coast market, targeting Boston, New Jersey, and the Research Triangle Park markets.
- Ability to accommodate an average workweek of approximately 45–50 hours, with significant additional and weekend hours potentially required by business-development opportunities and project demands.
- Ability to maintain average utilization on billable work, with targets of 50–75%.
- Ability to sign an employment agreement.
Responsibilities
- Manage, execute, and lead designated staff on assigned projects to ensure customer, sales, and service-delivery activities meet or exceed customer and company goals and expectations.
- Carry utilization targets on billable projects as a high-level or recognized market subject-matter expert; targets are 50–75% and are aligned with gross-margin goals for assigned accounts and the region.
- Manage and track annual revenue, margin, utilization, employee-retention, and client-rating goals.
- Develop strategies and tactics to achieve goals and update monthly goal reports.
- Support lead-generation activities as needed.
- Review, assess, and define requirements for contract scope and estimates.
- Provide technical depth and support relationship development with new-logo and existing-account sales and client-services teams during sales processes.
- Ensure services projects, initiatives, and processes conform to organizational and customer policies and objectives.
- Be accountable for solutioning and delivery methodologies, including evolving toward managed-service offerings using scalable people, process, and technology fundamentals.
- Ensure standards and consistency with every employee and client.
- Maintain accurate Salesforce Resource Planner information for assigned projects and accounts.
- Manage assigned staff utilization on assigned accounts and projects to optimize revenue, margin, and responsiveness to project needs.
- Manage team resourcing and forecasting for assigned projects to ensure appropriate staffing levels.
- Communicate staffing needs promptly to support effective sales.
- Communicate resource needs, required skill sets, and timing to HR and Talent Acquisition; work with Talent Acquisition to recruit an appropriate mix of subject-matter experts and new talent at target utilization levels.
- Interview prospective candidates and provide hiring and offer recommendations for executive approval.
- Support the performance-review process for employees by providing project-related feedback to their direct managers.
- Directly manage contractors on assigned-account projects, including client-site onboarding and offboarding and oversight of their time, delivery, and client interactions.
- Hold employees working on assigned accounts accountable when they do not meet expectations and provide appropriate feedback.
- Build a positive team environment and corporate culture, and provide input on marketing, the website, and growth strategies.
- Lead technical delivery and business development for assigned accounts and the Eastern region.
- Partner with service owners, sales, and client leadership to manage and grow service offerings and deliver a positive client experience.
- Work with regional heads and executive leadership to develop and ensure quality execution of services, new-business opportunities, talent development, and service packaging that optimizes profitability.
- Drive strategies and tactics related to industry leadership, customer value, expansion and growth, and collaboration and scale.
- Travel for client and employee check-ins, technical sales support, and billable consulting work.
Desired Qualifications
- Validation-program management and validation master-planning experience.
About the company
Verista provides business and technology consulting for life science companies, focusing on systems, compliance, validation and quality across the GxP lifecycle. Its services cover preclinical, clinical, commercialization, manufacturing and distribution to ensure safe, high-quality results. The company combines decades of industry knowledge with advanced engagement platforms and transformative technologies to help clients solve complex challenges with one partner across specialties. With a team of 500+ experts, Verista supports clients from strategy and validation to execution, delivering consistent, compliant outcomes that improve health and lives. The goal is to enable better health outcomes by ensuring products and processes are safe, compliant and efficient throughout the product development lifecycle.
Company Size
201-500
Company Stage
N/A
Total Funding
N/A
Headquarters
Fishers, Indiana
Founded
2020
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Simplify's Take
What believers are saying
- July 31, 2026 acquisition of Integral Solutions expands capacity and cross-sell.
- PACK EXPO 2026 and INTERPHEX 2026 keep Verista visible to pharmaceutical buyers.
- Verista's Sware partnership extends Res_Q digital validation workflows across regulated clients.
What critics are saying
- Kenyon v. Verista, filed April 2, 2026, signals active employment litigation.
- Carl Weiss v. Verista over ERISA benefits reached a February 2026 federal judgment.
- Acquisition-heavy growth invites integration slippage, margin pressure, and buyer skepticism against larger consultancies.
What makes Verista unique
- Verista combines CSV, CQV, validation, quality, and automation across the GxP lifecycle.
- COUNTQ and LABELQ deliver AI inspection and reconciliation for regulated packaging lines.
- Integral Solutions adds engineering and validation depth, widening Verista's turnkey implementation bench.
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Benefits
- Health Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Disability Insurance
- Health Savings Account/Flexible Spending Account
- 401(k) Company Match
- Paid Vacation
- Paid Sick Leave
- Paid Holidays
- Paid Parental Leave
- Bereavement Leave