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Quality Manager, NPI at PCI Pharma Services - ApplyBlast

Quality Manager, NPI

PCI Pharma Services

3 months ago

2.9 on Glassdoor

Remote

Full Time

Senior

4 applicants

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About this role

This senior leadership role oversees Quality Assurance and Design Control activities for New Product Introduction (NPI) projects within the pharmaceutical and medical device sectors. The position involves leading cross-functional teams, managing project timelines, ensuring regulatory compliance, and serving as an NPI risk management representative. Candidates must possess expert knowledge of quality systems and a strong background in advancing drug delivery products.

Responsibilities

Lead a team of Quality Professionals managing Design Control activities for NPI projects
Ensure delivery of all quality elements needed for new product introductions of combination products
Develop Advanced Drug Delivery Product Quality Assurance strategies supporting project development
Manage risks within the program ensuring proper identification and control through the lifecycle
Serve as an NPI risk management representative on cross-functional and multi-site teams

Skills

Qualifications

Bachelor's degree in engineering or Life SciencesExpert knowledge of 21 CFR Parts 820 and 11

About PCI Pharma Services

pci.com

Headquarters

Philadelphia, Pennsylvania, United States

Company Size

1001-5000 employees

View Profile

PCI is your world leading CDMO, providing integrated end-to-end drug development, manufacturing, and packaging solutions to increase product speed to market and opportunities for commercial success.