CQV Project Manager

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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Title: CQV Project Manager

Location: Warren, NJ

The CQV Project Manager supports the successful execution and delivery of assigned CQV projects through interaction with internal teams and customers, as well as external service providers.  The individual manages multiple projects of moderate to high complexity to ensure schedule and budget adherence.  The incumbent’s focus is support CQV projects executed by the ECQ department, such as new product introduction, facilities/utilities upgrade and modification, manufacturing and laboratory systems upgrade and modification, including release, relocation, and decommissioning/retirement.  The incumbent in this role is an individual contributor.

Key Responsibilities:

• Supervise execution of commissioning, qualification, and validation projects.
• Serve as a portfolio delivery lead for facilities and utilities.
• Develop and maintain CQV project scope documents, CQV budgets and schedules.
• Assist with interviewing external project personnel to fill necessary roles.
• Develop and continuously improve project management tools and templates using MS Office Suite applications, such as Project, PowerPoint, Excel, etc.
• Represent ECQ at project meetings.
• Regularly and efficiently communicate project status, including schedule, budget, resource loading, and any issues/challenges to ECQ management.
• Regularly review, prioritize, and promptly respond to business owners’ and ECQ functional managers’ requests regarding project scope, schedule, or budget.
• In cooperation with functional managers interface with customers to ensure all expectations are being met.
• Maintain a positive relationship with all the members of the Equipment Commissioning and Qualification department, PMO department, and site customers while promoting a positive team environment.
• In cooperation with ECQ functional managers, manage and prioritize staff workload across multiple projects and different departments that the ECQ organization serves.
• Maintain ECQ project schedules, and report ECQ timelines and task completion at project meetings.
• Continually seek opportunities to increase internal client satisfaction and deepen client relationships.

Qualifications & Experience:

• BS in Engineering or Science related discipline.
• Minimum of 5 years of experience in FDA-regulated industry.  A combination of relevant experience, education, and training is acceptable.
• Minimum of 3 years of experience managing projects, or 1 year of managing CQV projects in Cell Therapy industry.
• Knowledge of cGMP in the pharmaceutical industry.
• Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required.

• Strong project management skills and proven experience in having managed CQV projects with emphasis on Cell Therapy clinical and/or commercial manufacturing and analytical laboratories in cGMP environment.
• Familiarity with cell therapy manufacturing facilities, utilities, and laboratories, and requirements for their qualification.
• Understanding of construction and CQV terminology and documents, drawings, and diagrams.
• Familiarity with GMP, regulatory, and OSHA requirements as it pertains to facilities and utilities construction and operation.
• High proficiency in Microsoft Office Suite – Project, Word, Excel, PowerPoint, Visio, and Outlook.  Innate ability to develop and efficiently u