Senior Quality & Compliance Leader — Pharma Manufacturing

Medline Industries, LP; Waukegan (IL); On-site; USD 154,000 - 231,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP in Illinois seeks a Senior Quality Leader responsible for providing leadership and direction to the Quality team(s) to ensure quality and regulatory compliance for products and processes at the manufacturing site. Develop strategy, translate into functional plans and guide execution of long-term goals.

You will partner with Plant Operations to ensure optimal collaboration, drive continuous improvement, ensure readiness for internal and external audits, and act as liaison

Qualifications

• Bachelor’s degree in Engineering, Science, or Technical Field.
• 7+ years of experience in design/operation of medical device or drug product platforms with QSR/GMP/ISO/PQS/ICH knowledge.
• Advanced data analysis to identify issues and drive improvement.

Responsibilities

• Lead Quality team(s) and provide strategic direction for quality and regulatory compliance across the site.
• Partner with Plant Operations to drive continuous improvement and optimize cross-functional collaboration.
• Ensure site readiness for internal audits, external regulatory audits, and customer visits.

Skills

Quality management

Regulatory compliance

Cross-functional leadership

Excel proficiency

Data analysis

Education

Bachelor’s degree in Engineering, Science, or Technical Field

Tools

Microsoft Excel

QMS software

Job description

Medline Industries, LP in Illinois seeks a Senior Quality Leader responsible for providing leadership and direction to the Quality team(s) to ensure quality and regulatory compliance for products and processes at the manufacturing site. Develop strategy, translate into functional plans and guide execution of long-term goals.

You will partner with Plant Operations to ensure optimal collaboration, drive continuous improvement, ensure readiness for internal and external audits, and act as liaison