Reports to: Director, Quality CMC
Location: Remote work, US Only
Position Summary: The Senior Manager, Quality CMC DP serves as primary Quality representative supporting vaccine DP manufacturing from clinical development through late-stage development, Process Performance Qualification (PPQ) readiness, licensure preparation, and commercialization. The role provides current Good Manufacturing Practices (cGMP) quality oversight for external DP manufacturing, aseptic processing, fill-finish operations, technology transfer, process validation, PPQ, commercial readiness, inspection readiness, and product disposition activities.
This position partners with CMC and Regulatory Affairs and external manufacturing organizations to ensure compliant manufacture, testing, release, and lifecycle management of vaccine DP in accordance with global cGMP requirements and regulatory expectations. The successful candidate will possess extensive DP quality experience supporting technology transfer, process validation, PPQ execution, health authority interactions, and commercialization readiness while ensuring manufacturing systems and quality processes remain compliant, scalable, and inspection ready.
Key Responsibilities: - Serve as primary Quality representative, providing cGMP oversight and risk-based quality decision-making across clinical and late-stage DP activities.
- Provide Quality oversight for clinical manufacturing, engineering runs, technology transfer, scale-up activities, process validation, and PPQ readiness.
- Participate in manufacturing readiness reviews and provide Quality approval for validation, media fills, PPQ execution, and commercial readiness activities.
- Review batch records, deviations, investigations, analytical and stability data, environmental monitoring results, and change controls to support product disposition decisions.
- Approve deviations, Corrective and Preventative Actions (CAPAs), change controls, risk assessments, and quality records supporting compliant operations.
- Provide Quality oversight of Contract Development Manufacturing Organizations (CDMOs) and contract laboratories, including supplier qualification, audits, inspection support, and CAPA implementation.
- Support preparation of quality documentation and responses associated with Biological License Application (BLA), Marketing Authorization Application (MAA), and other regulatory submissions.
- Support regulatory inspections, including the Food and Drug Administration (FDA) inspections, Bioresearch Monitoring (BIMO) inspections, and Pre-Approval Inspections (PAIs).
- Lead the development, implementation, and continuous improvement of Sabin's Quality Management System, quality governance, and sponsor oversight processes to support the organization's transition to a fully compliant global Marketing Authorization Holder (MAH).
Requirements
- Bachelor's or advanced degree in scientific discipline.
- 9+ years of Quality experience supporting biologics, vaccines, or pharmaceutical DP manufacturing.
- Proven experience supporting technology transfer, process validation, PPQ execution, manufacturing readiness, and commercial launch preparation.
- Demonstrated experience providing Quality oversight of aseptic manufacturing and fill-finish CDMOs.
- Experience supporting FDA inspections, BIMO inspections, and/or PAIs.
- Strong knowledge of 21 CFR Parts 210 and 211, Annex 1, ICH Q10, and global cGMP requirements applicable to sterile drug product manufacturing.
- Experience supporting BLA, MAA, or equivalent regulatory submissions preferred.
- Occasional travel required to support organizational alignment and business needs.
Other: - Subject to a criminal background investigation
- Request for three professional references
- Verification of education/degrees
Sabin's philosophy is to ensure fair, unbiased, equitable, competitive compensation and benefits. Using benchmarking and salary survey data, the annual salary for this position ranges from $135,000 - $165,000. The exact compensation may vary based on skills, experience, training, and certifications/degree. As a grant-funded organization, Sabin actively seeks funding for existing and new programs.
Sabin provides a comprehensive benefits package that includes medical, dental, and vision coverage, as well as flexible spending accounts. Eligible employees receive flexible vacation and sick leave, along with employer-paid life and disability insurance. The organization observes 11 federal holidays and an end-of-year winter break. Sabin also offers an employer-matching 401(k) plan.
Salary Description
$135,000 - $165,000
