Pharma QA Contract Lead—GMP/CMO Oversight

BeOne Medicines; San Carlos (CA); On-site; USD 37,000 - 49,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401(k)

Job summary

BeOne Medicines is seeking a temporary QA Manager to oversee quality events, labeling reviews, and vendor performance within its Contingent Workforce Program in partnership with Magnit Global. You will work with CMOs under GMP constraints and ensure deviation, complaint, and change-control processes meet BeOne SOPs.

The role requires 3+ years in QA management, familiarity with cGMP, GDP, and GCP, and a Bachelor's in Pharmaceutics or Chemistry.

Qualifications

• 3+ years in quality assurance management with CMOs.
• Familiarity with cGMP, GDP, and GCP is a plus.
• Ability to analyze and resolve issues independently.

Responsibilities

• Quality events management such as deviation, complaint, and change control to ensure events handling meet GMP/QAA requirements.
• Oversee labeling/relabeling at CMOs and approve labeling batch records.
• Comparator Product Release prior to secondary packaging operations.
• Review and approve Supply Chain Table Part I & II, including QA input for Change Control.
• Clinical Label Compliance Review and Approval.
• Vendor performance monitoring and periodic assessment.
• Review/revise QAA between BeOne and external packaging sites.

Skills

Quality assurance management

CMO collaboration

GMP knowledge

Problem solving

Education

Bachelor’s degree in Pharmaceutics or Chemistry

Job description

BeOne Medicines is seeking a temporary QA Manager to oversee quality events, labeling reviews, and vendor performance within its Contingent Workforce Program in partnership with Magnit Global. You will work with CMOs under GMP constraints and ensure deviation, complaint, and change-control processes meet BeOne SOPs.

The role requires 3+ years in QA management, familiarity with cGMP, GDP, and GCP, and a Bachelor's in Pharmaceutics or Chemistry.