6443 - CQV Project Manager / Project Manager SME
About The Position
Verista is seeking a Project Manager SME to lead the C&Q delivery team for a GMP viral vector facility build-out in Devens, MA. This role will cover both LVV drug substance manufacturing areas and the drug product filling suite. The individual will manage the project like a controlled capital project, encompassing integrated staffing, schedule logic, earned-value progress tracking, deliverable governance, field execution readiness, deviation/change control, and closeout processes including green tag/blue tag and final qualification reporting. Verista is a company with 500 experts that partners with recognizable brands in the life science industry to solve business needs, empower growth and innovation, and help improve healthcare challenges. The company culture emphasizes empowering and supporting colleagues, client success, courage, inclusivity, and continuous learning.
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.
- Ability to be on-site, full-time in Devens, MA.
Nice To Haves
- ValGenesis experience a plus
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
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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Associate degree
