Remote Senior QA Validation Lead – Drug Packaging

SimulStat Incorporated; United States; Remote; USD 120,000 - 170,000; Full time

Benefits offered by this job

Remote work

12-month contract

Job summary

SimulStat Incorporated is seeking an experienced QA professional for a remote, 12-month contract in the United States. The role leads QA oversight of transport and packaging validation at CMOs, and serves on cross-functional teams ensuring compliance with current global regulations.

The ideal candidate has 8+ years in pharma, with strong GMP knowledge and the ability to manage multiple priorities under tight timelines.

Qualifications

• Bachelor’s degree in a scientific or technical discipline.
• 8+ years of pharmaceutical industry experience.
• QA oversight of transport validation and packaging validation preferred.
• Experience with QA for CMOs quality, validation, packaging and testing.
• Strong knowledge of US and global GMP regulations.

Responsibilities

• Lead QA oversight of transport validation and packaging validation for drug product and finished packaged product at CMOs to support commercial readiness.
• Serve as QA representative on cross-functional teams, providing guidance on quality and compliance.
• Act as QA SME on deviations, CAPAs, change controls, and documentation revisions.
• Review and approve CMO documentation, including specifications, batch records, label proofs, and validation documentation.
• Establish and report quality metrics, risks, and compliance challenges to senior management.
• Periodically review and revise GMP SOPs and procedures.
• Support inspection readiness for commercial launch.

Skills

QA oversight

Regulatory compliance

Cross-functional collaboration

Project management

Timelines management

Education

Bachelor's degree

Job description

SimulStat Incorporated is seeking an experienced QA professional for a remote, 12-month contract in the United States. The role leads QA oversight of transport and packaging validation at CMOs, and serves on cross-functional teams ensuring compliance with current global regulations.

The ideal candidate has 8+ years in pharma, with strong GMP knowledge and the ability to manage multiple priorities under tight timelines.