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. This person needs to run the work like a controlled capital project: integrated staffing, schedule logic, earned-value style progress tracking, deliverable governance, field execution readiness, deviation/change control, and closeout through green tag/blue tag and final qualification reporting.
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
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.National (US) Range
$107,800-$168,011 USD
BenefitsWhy 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
For more information about our company, please visit us at Verista.com
