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.

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

: 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.

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.

Supplemental Life, Hospi

6443 - CQV Project Manager / Project Manager SME