CQV Project Manager

Posted 4 Days Ago
Be an Early Applicant
Warren, NJ
Senior level
Healthtech
The Role
The CQV Project Manager oversees the execution of commissioning, qualification, and validation projects, manages project scopes, budgets, and schedules, and ensures compliance with regulations in the pharmaceutical industry while leading internal teams and liaising with customers.
Summary Generated by Built In

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.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

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 use scheduling and budgeting tools and presentations, as well as learn new software, such as corporate intranet and enterprise business applications.
  • Advanced understanding and working knowledge of project scheduling, budgets, and execution principles.
  • Excellent written and verbal communication skills. 
  • Excellent interpersonal skills with experience dealing with a diverse workforce.
  • Strong multi‐tasking ability in conjunction with proven organizational skills.
  • Pro-active in solving challenging project issues with the ability to develop creative solutions.
  • Familiarity with electronic document management and quality management systems, such as Veeva Vault, Infinity, etc.
  • Familiarity with electronic inventory management systems, such as BMRAM, Maximo, etc.
  • Ability to create and analyze meaningful metrics.

#LI-Onsite

BMSCART

VETERAN

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

The Company
HQ: Lawrence Township, NJ
40,384 Employees
On-site Workplace

What We Do

At Bristol Myers Squibb, we work every day to transform patients’ lives through science. That work inspires some of the most interesting, meaningful, and life-changing careers you’ll experience. Join us and pursue innovative ideas alongside some of the brightest minds in biopharma, collaborating with a team rich in diversity of experiences, and perspectives. We have built a sustainable pipeline of potential therapies and are leveraging translational medicine and data analytics to understand how we can deliver the right medicine to the right patient, at the right time, to achieve the best outcome.

Whether in a scientific, business or supporting function, a career at BMS means you’ll be inspired every day to grow and thrive through opportunities that are uncommon in scale and scope. Here, you’ll be on the cutting edge of powerful innovation in oncology, hematology, immunology, cardiovascular disease, and fibrosis, with colleagues united in the mission to help patients.

Through the Bristol Myers Squibb Foundation, we also promote health equity and seek to improve health outcomes of populations disproportionately affected by serious diseases and conditions. Our mission is to give new hope to help patients prevail over serious disease – it drives everything we do.

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