Validation SME - Delivery Leader

Validation SME - Delivery Leader

The Validation SME - Delivery Leader will focus on technical delivery and business development across the Eastern United States. The company operates a matrixed structure, so delivery operations work with client services leadership and sales to manage delivery and the client experience together. The successful candidate will be responsible for managing and growing all revenue across their assigned accounts and region.

The Validation SME will:

• Provide positive leadership across all assigned accounts and projects
• Manage and grow service offerings in partnership with service owners, sales and client leadership
• Work as a cross-functional expert with Regional Heads and the Executive Leadership Team
• Make sure services are delivered to a high standard
• Develop new business opportunities and talent
• Package services to optimize profitability

The successful candidate will help drive the company's mission to be a leading provider of automation and compliance solutions across the regulated IT/OT environment. This includes leading strategy and tactics in four areas:

• Industry Leadership
• Customer Value
• Expansion and Growth
• Collaboration and Scale

The individual will be expected to set an example of hard work, a positive attitude, commitment to customer satisfaction and strong interpersonal skills.

Key Responsibilities

• Manage, execute and lead designated staff on assigned projects, making sure customer, sales and service delivery activities meet or exceed customer and company goals
• Carry a billable utilization target of 50-75% as a recognized market SME. The exact target will align with gross margin goals for the assigned accounts and region.
• Manage and track annual goals, including revenue, margin, utilization, employee retention and client rating
• Develop strategies and tactics to meet goals, and update monthly goal reports

Sales and New Engagement

• Support lead generation activities as required
• Review, assess and define requirements for contract scope and estimation
• Provide technical depth and support relationship development with sales and client services teams for both new and existing accounts

Project Implementation and Execution

• Make sure all projects, initiatives and processes conform to company and customer policies and objectives
• Take accountability for solutioning and delivery methodologies, including the move towards more managed service offerings built on scalable people, process and technology fundamentals
• Maintain consistent standards with every employee and client
• Keep resource planning records accurate for assigned projects and accounts

Employee Development and Staffing

• Manage staff utilization on assigned accounts to optimize revenue, margin and responsiveness to project needs
• Manage team resourcing and forecasting to maintain appropriate staffing levels
• Communicate staffing needs clearly and promptly to support effective sales
• Work with HR and Talent Acquisition on resource needs, recruiting the right mix of SMEs and new talent at the target utilization level
• Interview candidates and make hiring and offer recommendations for executive approval
• Give project-related performance feedback to employees' direct managers
• Directly manage all contractors on assigned accounts, including onboarding and offboarding at client sites, time, delivery and client interactions
• Set high expectations, challenge employees to perform at their best and hold them accountable where needed
• Build a team environment with high morale and a positive culture, and contribute ideas on marketing and growth strategy

Education

• Bachelor's degree in a technical (STEM) discipline

Experience

• 15+ years of engineering experience in a GMP-regulated environment, with direct pharmaceutical or medical device validation experience
• 5+ years of professional services and consulting experience
• 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 (GDP) in a pharmaceutical environment
• ASTM E2500
• ISO 14971 (risk management for medical devices)
• ISPE Applied Risk Management for C&Q
• ISPE Science and Risk-Based Approach for the delivery of facilities, systems and equipment
• ICH Q8, Q9 and Q10 (risk management and risk analysis tools)
• In-depth knowledge of process, manufacturing and/or packaging equipment validation within life sciences or GMP
• CQV and CSV expertise across equipment and associated software systems
• Holistic understanding of process systems, including work processes, optimization methods, risk management and project management
• Experience in a fast-paced, high-growth, results-driven organization
• Project management experience across multiple projects ranging from $50K to more than $5M
• Supervisory experience managing at least 20 people, including 3-5 direct reports
• Background in internal and external CSV and CQV validation
• Recognized for knowledge of industry best practices in developing validation standards for pharma and biotech
• Validation program management and validation master planning experience preferred

Skills

• Confident presenting to and working with a wide range of stakeholders, from C-level executives to project managers, plant engineers, supervisors and operators
• Able to negotiate strategically in high-pressure situations involving:
• Project and technical issues
• Funding and change orders
• Employee performance
• Proven record of strong leadership, deep practical validation knowledge, on-time project delivery, cost control and customer satisfaction
• Able to give colleagues practical, specific guidance on industry and regulatory requirements
• Intermediate to expert skills in Microsoft Word, Excel and Project
• Excellent written and verbal English communication skills
• A calm, composed leader who can guide teams through demanding client-facing projects
• Understanding of laboratory and automated manufacturing and assembly equipment, such as PLCs, HMIs and PC-based controls
• Understanding of enterprise-level systems commonly used in pharma and biotech
• Highly skilled in authoring, editing and executing validation documents for equipment, facilities and utilities

Supervisory Scope The successful candidate will manage the projects of employees and contractors across their portfolio. This is not an internal line management position, so it does not include direct growth and development oversight of full-time employees. Instead, the individual will work with employees' direct managers to provide feedback and performance support. They will directly manage all contractors on assigned projects in line with the contract terms.

Work Environment

• Most work takes place at client sites. This involves regular travel for client and employee check-ins, technical sales support and billable consulting work.
• The candidate must live within a daily commute of an East Coast hub, with Boston, New Jersey and Research Triangle Park (RTP) as the target markets.
• Travel is typically around 50% but varies with client and project needs.
• Average working hours are 45-50 per week. Business development and tight project deadlines may sometimes require longer hours or weekend work.
• The role must maintain an average billable utilization of 50-75%, aligned with gross margin targets for the assigned accounts and region.
• The successful candidate will sign an employment agreement and will be eligible for Senior Leadership Incentive programs.