6443 - CQV Project Manager / Project Manager SME

Description

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

• 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

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.

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