Senior Manager, Quality Chemistry Manufacturing and Controls – Drug Product

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the primary representative for Quality, offering cGMP oversight and making risk-based quality decisions throughout clinical and late-stage drug product activities.

• Deliver Quality oversight for clinical manufacturing, engineering runs, technology transfer, scale-up processes, process validation, and readiness for PPQ.

• Engage in manufacturing readiness assessments and provide Quality approval for validation, media fills, execution of PPQ, and activities related to commercial readiness.

• Evaluate batch records, deviations, investigations, analytical data, stability results, environmental monitoring findings, and change controls to assist in product disposition decisions.

• Sanction deviations, Corrective and Preventative Actions (CAPAs), change controls, risk assessments, and quality documentation that support compliant operations.

• Oversee Quality aspects of Contract Development Manufacturing Organizations (CDMOs) and contract laboratories, including supplier qualification, audits, inspection assistance, and CAPA execution.

• Assist in the preparation of quality documentation and responses related to Biological License Applications (BLA), Marketing Authorization Applications (MAA), and other regulatory submissions.

• Aid in regulatory inspections, including those conducted by the Food and Drug Administration (FDA), Bioresearch Monitoring (BIMO), and Pre-Approval Inspections (PAIs).

• Spearhead the development, execution, and continuous enhancement of Sabin's Quality Management System, quality governance, and sponsor oversight processes to facilitate the organization's shift to a fully compliant global Marketing Authorization Holder (MAH).

⛳️ Requirements

• Bachelor’s or higher degree in a scientific field.

• Over 9 years of Quality experience in biologics, vaccines, or pharmaceutical drug product manufacturing.

• Proven track record in supporting technology transfer, process validation, execution of PPQ, manufacturing readiness, and preparation for commercial launches.

• Demonstrated expertise in providing Quality oversight for aseptic manufacturing and fill-finish CDMOs.

• Experience in supporting FDA inspections, BIMO inspections, and/or Pre-Approval Inspections (PAIs).

• In-depth knowledge of 21 CFR Parts 210 and 211, Annex 1, ICH Q10, and global cGMP standards relevant to sterile drug product manufacturing.

• Prior experience with BLA, MAA, or similar regulatory submissions is preferred.

• Willingness to travel occasionally to ensure organizational alignment and meet business needs.

🏝️ Benefits

• Medical, dental, and vision coverage.

• Flexible spending accounts.

• Flexible vacation and sick leave.

• Employer-paid life and disability insurance.

• 11 federal holidays.

• Year-end winter break.

• Employer-matching 401(k) plan.