Senior Manager, Quality Assurance

Katalyst-Healthcares-; New York (NY); On-site; USD 120,000 - 190,000; Full time

Job summary

Katalyst-Healthcares- is seeking an experienced QA leader to oversee transport validation and packaging validation for drug product and finished packaging at CMOs, ensuring commercial readiness. You will act as the QA SME on deviations, CAPAs, change controls, and documentation revisions while reviewing critical CMO documents and maintaining GMP SOPs.

Strong collaboration across functions is essential for tight timelines.

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.

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.
• Act 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.

Skills

QA oversight

Regulatory compliance

Cross-functional leadership

Deviations & CAPA

Documentation & approvals

GMP & SOPs

Inspection readiness

Education

Bachelor's degree in a scientific or technical discipline

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.
• Act 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.