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. 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. Responsibilities 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 Qualifications Bachelor’s Degree or equivalent required 8–12+ years GMP CQV project leadership CQV lifecycle planning and execution controls Protocol review governance and approval readiness Biologics/cell and gene therapy facility startup 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 Location Requirements This role requires the ability to be on-site, full-time in Devens, MA. 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 Supplemental life, hospital, critical illness and legal insurance Health savings account Paid time off (rollover option) and holidays As needed sick time Tuition reimbursement Team social activities Employee recognitionEmployee referral program Paid parental leave and bereavement Salary Range (National US)

$107,800 – $168,011 USD