Remote Quality Leader - NPI & Design Control

PCI TRGR Penn Pharmaceutical Services Ltd; Illinois; Remote; USD 87,000 - 98,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Flexible spending account

Paid time off

Job summary

PCI Pharma Services is seeking a senior Quality Assurance leader to oversee Design Control activities for new product introductions (NPIs) in a fully remote role. You will lead cross-functional teams, shape QA strategy, and ensure regulatory conformance across complex drug-device combinations.

The ideal candidate holds a science/engineering degree and 10+ years in pharmaceutical/biotech/medical device quality, with deep knowledge of GAMP 5 and CFR regulations.

Qualifications

• Bachelor’s degree in engineering, Life Sciences, or related technical discipline.
• Minimum of 10+ years of progressive experience within pharmaceutical, biotech, or medical device industries.
• Expert knowledge of GAMP 5, 21 CFR Parts 820, 210/211, and 11, and data integrity regulations.
• Strong understanding of Product Life Cycle Management, Design Assurance, and Project Management.

Responsibilities

• Lead a team of Quality Professionals responsible for managing Design Control activities for NPI projects.
• Ensure delivery of quality elements needed to facilitate new product introductions.
• Develop Advanced Drug Delivery Product Quality Assurance strategies and implements agreed strategy to support the development of NPI projects.
• Collaborate with internal stakeholders and clients on issue management, escalation, evaluation, and resolution for quality, operational, and regulatory concerns.

Skills

GAMP 5

Data integrity

Lifecycle management

Regulatory compliance

Education

Bachelor’s degree in engineering, Life Sciences, or related technical discipline

Job description

PCI Pharma Services is seeking a senior Quality Assurance leader to oversee Design Control activities for new product introductions (NPIs) in a fully remote role. You will lead cross-functional teams, shape QA strategy, and ensure regulatory conformance across complex drug-device combinations.

The ideal candidate holds a science/engineering degree and 10+ years in pharmaceutical/biotech/medical device quality, with deep knowledge of GAMP 5 and CFR regulations.