Project Manager, Investigational Product Quality Assurance

Pay Range

$88,800.00-$142,200.00

Company Overview

The people of Memorial Sloan Kettering Cancer Center (MSK) are united by a singular mission: ending cancer for life. Our specialized care teams provide personalized, compassionate, expert care to patients of all ages. Informed by basic research done at our Sloan Kettering Institute, scientists across MSK collaborate to conduct innovative translational and clinical research that is driving a revolution in our understanding of cancer as a disease and improving the ability to prevent, diagnose, and treat it. MSK is dedicated to training the next generation of scientists and clinicians, who go on to pursue our mission at MSK and around the globe. 

 

Please review important announcements about vaccination requirements and our upcoming EHR implementation by clicking here.

 

Important Note for MSK Employees: 

Your Career Hub profile is submitted to the hiring team as your internal resume. Please be sure your profile is fully complete with your skills, relevant experience and education (if required). Click here to learn more. Please note, this link is only accessible for MSK employees.  

Job Description

Investigational Product Quality Assurance unit (IPQA) supports our Member Laboratories and Facilities in meeting regulatory expectations for Good Manufacturing Practices (GMP) and Quality Management Systems (QMS) for therapeutic and diagnostic investigational drugs, biologics, and devices.  IPQA oversees the safety and quality of these investigational products by providing, but not limited to, the following services:

• Good Manufacturing/Good Documentation Practices (GMP/GDP) Training
• Quality System Development
• Document Writing and Review
• Member Laboratory Audits
• CAPA Investigations and Troubleshooting
• Validation and Change Control

You will:

• Support the management and execution of projects through all phases of the project life cycle, including initiation, needs assessment, requirements and specifications, implementation, and maintenance to approved budget, scope and schedule.
• Collaborate with investigators internally and externally to ensure appropriate/timely responses.
• Engage and advise faculty leadership, administration and external collaborators throughout the project, obtaining critical decisions and guidance, and ensuring continuous departmental and organizational commitment.
• Help manage risk throughout the project life cycle and makes contingency plans to manage issues that pose risk to budget, timely delivery, or functionality.
• Help with effectively scoping projects and establishing metrics that will be used to measure success.
• Develop and maintain structured project plans and action items.
• Set project management timelines and manages partner expectations, proactively resolving conflict to successfully meet project timelines and deliverables.
• Lead meetings of project workgroups, including facilitating discussion about projects.
• Create presentations for progress reports, including relevant visual presentation materials and written narrative as needed.

You need:

• 2-4 years of project related experience in cell therapy and cell engineering.
• Excellent leadership skills.
• Flexibility and forward-thinking approach to the way the work is done.
• Ability to work on multiple projects while prioritizing, and meeting deadlines.
• Outstanding attention to detail and strong analytical and interpersonal skills.
• Excellent communication skills and the ability to interact across all levels in a confident, professional manner.

Schedule is hybrid, with the expectation to be onsite as needed (1-3 days a week on average).

 

Are you ready to learn more about our Benefits?

 

Pay Range $88,800.00-$142,200.00

 

Please click to learn more about MSK’s compensation philosophy.

Closing

MSK is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sexual orientation, national origin, age, religion, creed, disability, veteran status or any other factor which cannot lawfully be used as a basis for an employment decision.  

 

Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require