Validation SME - Delivery Leader

The role

The Validation SME - Delivery Leader manages revenue, technical delivery, and business development in the Eastern US region. This role leads staff on projects, manages service offerings, and ensures quality execution of services for life science clients.

What you will do

• Manage, execute and lead designated staff on assigned projects
• Carry utilization targets in the 50-75% range
• Manage and track annual goals including Revenue, Margin, Utilization, Employee Retention, and Client Rating
• Support lead generation and new business development
• Review, assess and define requirements for scope and estimation of contracts
• Ensure services projects and processes conform to organization and customer policies
• Manage team resourcing and forecasting for assigned projects
• Interview prospective candidates and provide hiring recommendations
• Support the performance review process for Verista FTE employees
• Direct management of all contractors on projects at assigned accounts

Required qualifications

• Bachelor’s degree in a technical (STEM) discipline
• 15+ years’ engineering experience in GMP regulated environment with direct experience in pharmaceutical or medical device validation
• 5+ years’ professional services and consulting experience
• 5+ years’ experience in professional services business development and customer relations
• Expert knowledge of FDA regulations, ISPE guidelines and ISO standards including GAMP5, GDP, ASTM-E2500, ISO 14971, ISPE Applied Risk Management for C&Q, ISPE Science and Risk Based Approach, and ICH
• In depth knowledge of process, manufacturing, and/or packaging equipment validation within Life Sciences or GMP
• CQV and CSV expertise with equipment and associated software systems
• Experience in Project Management managing projects from $50K to over $5MM
• Prior supervisory experience managing at least 20 people and at least 3-5 direct reports
• Background in internal and external CSV and CQV validation
• Intermediate to expert skills with WORD, EXCEL and PROJECT
• Excellent English communication skills (written and verbal)

Nice to have

• validation program management and validation master planning experience

Benefits

• High growth potential and fast-paced organization
• 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

Before you apply

• Must reside within a daily commutable distance of Boston, NJ, or RTP markets
• Required to sign an Employment agreement document

About the company

Verista's 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The company provides innovative solutions and services that empower informed decision-making.