Bachelor's degree in a scientific or technical discipline.
8+ years of pharmaceutical industry experience.
Strongly preferred: QA oversight of transport and packaging validation.
Experience managing quality aspects at CMOs.
Familiarity with process validation and inspection readiness.
Solid knowledge of US and global GMP regulations.
Strong collaboration and management skills.
Responsibilities
Lead QA oversight of transport and packaging validation for drug products.
Serve as QA representative on cross-functional teams for quality guidance.
Act as QA SME on deviations, CAPAs, and documentation revisions.
Review and approve CMO documentation including specifications and batch records.
Establish and report quality metrics and compliance challenges to management.
Periodically review and revise GMP SOPs and procedures.
Support inspection readiness for commercial launch.
Benefits
Comprehensive health insurance options.
Retirement savings plan with company match.
Professional development opportunities.
Flexible work arrangements.
Generous paid time off policy.
Full Job Description
Responsibilities:
Lead QA oversight of transport validation and primary/secondary 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 based on current global regulations and industry standards.
ct as QA SME on deviations, CAPAs, change controls, and documentation revisions.
Review and approve CMO documentation, including specifications, master and executed 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.
Qualifications:
Bachelor's degree in a scientific or technical discipline.
8+ years of pharmaceutical industry experience.
Demonstrated QA oversight of transport validation and packaging process validation strongly preferred.
Experience managing quality aspects of validation, packaging, and testing at CMOs.
Experience with process validation (PPQ), commercial readiness, and domestic/ex-US inspection readiness.
Solid knowledge of US and global GMP regulations and industry practices.
Strong collaboration and management skills with the ability to handle multiple priorities on aggressive timelines.
