Verista, Inc.

Verista, Inc.

6443 - CQV Project Manager / Project Manager SME

Devens, Massachusetts · Full-time

Sponsorship not specified$108k-$168kDetected 13 days ago
Project ManagementStakeholder ManagementCadenceGMPFDA RegulatoryCRISPRLeadershipCommunication

About the role

  • 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.

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

Requirements

  • Bachelor's Degree or equivalent required
  • 8-12+ years GMP CQV project leadership
  • Comfort with lump-sum controls
  • Strong knowledge of FDA, EU GMP, ISPE, ASTM E2500, and GAMP 5

Nice to have

  • ValGenesis experience a plus
  • Competitive pay plus performance-based incentive programs

Compensation

  • For US geography, the salary range for this position is shown below.

Benefits

  • Company-paid Life, Short-Term, and Long-Term Disability Insurance.
  • Medical, Dental & Vision insurances
  • FSA, DCARE, Commuter Benefits
  • Health Savings Account
  • 401(k) Retirement Plan (Employer Matching benefit)
  • Paid Time Off (Rollover Option) and Holidays
  • Tuition Reimbursement
  • Paid Parental Leave and Bereavement

Company info

  • 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
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