6443 - CQV Project Manager / Project Manager SME

United States·Devensmid

OperationsProject Manager

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Quick Summary

Key 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.

Requirements Summary

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.

Technical Tools

OperationsProject Manager

Description

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

Responsibilities

~1 min read

→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

Requirements

~2 min read

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

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

For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.

*Verista is an equal opportunity employer.

National (US) Range

$107,800—$168,011 USD

Benefits

Why Choose Verista?

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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For more information about our company, please visit us at Verista.com