Global Quality Compliance Lead – Sterile & OSD

Sun Pharmaceutical Industries, Inc.; Princeton (NJ); On-site; USD 101,000 - 112,500; Full time

Benefits offered by this job

Annual Performance Bonus Plan

Medical, dental, and vision coverage

401(k) savings plan

Job summary

A leading pharmaceutical company is seeking a Manager of Global Quality Compliance to oversee the review of manufacturing and packaging records, ensuring compliance with FDA regulations and Good Manufacturing Practices (GMP). This role requires a strong understanding of sterile manufacturing, with responsibilities including training colleagues, leading compliance reviews, and identifying areas for continuous improvement. The ideal candidate will have a Bachelor's degree and at least five years of experience in the pharmaceutical industry.

Qualifications

• Minimum of Bachelor’s degree.
• Thorough understanding of GMPs related to good documentation practices.
• Strong communication, interpersonal, and organizational skills.

Responsibilities

• Manage overall batch review of manufacturing/packaging records.
• Lead compliance reviews for FDA inspections.
• Identify compliance concerns and support continuous improvements.

Skills

GMP understanding

Communication skills

Interpersonal skills

Organizational skills

Project management knowledge

Education

Bachelor’s degree

Tools

MS Office

TrackWise

LMS

Job description

A leading pharmaceutical company is seeking a Manager of Global Quality Compliance to oversee the review of manufacturing and packaging records, ensuring compliance with FDA regulations and Good Manufacturing Practices (GMP). This role requires a strong understanding of sterile manufacturing, with responsibilities including training colleagues, leading compliance reviews, and identifying areas for continuous improvement. The ideal candidate will have a Bachelor's degree and at least five years of experience in the pharmaceutical industry.