6443 - CQV Project Manager / Project Manager SME

Job Overview

We are seeking a Project Manager SME to lead the C&Q delivery team for a GMP viral vector facility build-out in Devens, MA, covering both LVV drug substance manufacturing areas and the drug product filling suite.

Project Manager SME Responsibilities

• Own day-to-day CQV delivery
• Interface with owner C&Q lead / project manager
• Lead meetings and manage staffing, budget, schedule, risks, trends, action log, change log, and recovery plans.
• Own team roster, distribution matrix, meeting cadence, minutes, action log, risk log, trend/change log, monthly report, staffing forecast, and recovery plans
• Drive alignment between construction turnover, commissioning readiness, mechanical completion, PSSR, green tag, blue tag, and qualification execution
• Ensure document quality expectations are met before owner review: correct formatting, legible execution packages, GDP compliance, complete evidence, and traceable comments/resolutions
• Coordinate resourcing for onsite walkdowns, SAT/commissioning/IOQ/PQ execution windows, and closeout support through March 2027 with possible April 2027 extension

Job Requirements

• Bachelor’s Degree or equivalent required
• 8-12+ years GMP CQV project leadership
• Successful capital project delivery
• CQV lifecycle planning and execution controls
• Protocol review governance and approval readiness
• Biologics/cell and gene therapy facility startup
• Strong owner/site stakeholder management
• Risk/change/deviation management
• Comfort with lump-sum controls
• Strong knowledge of FDA, EU GMP, ISPE, ASTM E2500, and GAMP 5
• Excellent leadership, communication, and stakeholder management skills.
• ValGenesis experience a plus

Company Culture Guidelines & Values

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

Benefits

• High growth potential and fast-paced organization with a people-focused culture
• 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 (We have fun!)
• Employee Recognition
• Employee Referral Program
• Paid Parental Leave and Bereavement

Pay

*Verista is an equal opportunity employer.

National (US) Range
$107,800 - $168,011 USD

Schedule

This role requires the ability to be on-site, full-time in Devens, MA.