Location: New Haven, CT (Northeast Preferred)

Position Summary:

The Senior Quality Manager helps to establish, oversee, update, and maintain drug substance and drug product testing.  The ideal candidate is an experienced leader with deep expertise in biopharmaceutical QC release testing and a strong track record of managing external testing partners. This is an opportunity to contribute meaningfully to a growing organization where your insights, leadership, and technical excellence will directly influence program success.

Responsibilities:

• Lead and coordinate external testing activities for drug substance (DS) and drug product (DP) release and stability programs, including comprehensive review and approval of protocols, reports, and complete raw data packages to ensure accuracy, compliance, and readiness for regulatory use.
• Serve as the QC analytical subject matter expert (SME) by providing technical guidance to external partners on analytical method qualification, validation, transfer, and maintenance for DS and DP methods.
• Perform detailed data trending and statistical analysis of DS/DP release and stability results, proactively identifying shifts in performance and leading timely root-cause evaluation of out-of-trend (OOT) and out-of-specification (OOS) events, including coordination of investigations and implementation of effective corrective/preventive actions.
• Collaborate cross-functionally to establish, justify, and maintain phase-appropriate DS and DP specifications that align with regulatory expectations and quality standards.
• Manage and support QC-related quality events, including initiation, assessment, and closure of change controls, deviations, OOS/OOT investigations, CAPAs, and other exceptions, ensuring thorough documentation, timely resolution, and compliance with internal and external requirements.
• Author, revise, and approve high-quality procedures and documentation that support compliant QC operations.
• Provide technical expertise for regulatory filings, including preparation and review of QC-related sections for regulatory submissions (INDs, BLAs, and other filings). Support responses to regulatory queries and inspections by providing clear, scientifically sound justifications.

Competencies:

• Exceptional written and verbal communication skills, with the ability to convey complex technical concepts clearly.
• Strong attention to detail and a high commitment to data integrity and quality standards.
• Highly organized with the ability to manage multiple priorities in a fast-paced environment.
• Resourceful and proactive problem-solver who thrives in a dynamic, entrepreneurial setting.
• Adaptable and able to respond effectively to shifting priorities and business needs.
• Collaborative team player with the ability to build strong relationships across internal and external partners.
• Able to work both independently and as part of cross-functional teams.

Requirements:

• Bachelor’s or Master’s degree in a scientific discipline with 10+ years of experience in the biopharmaceutical industry.
• Minimum 5 years in a Quality-focused role supporting QC operations.
• Demonstrated experience managing DS/DP release testing.
• High proficiency with MS Office and statistical/analytics platforms (e.g., JMP).
• Strong experience managing external testing laboratories (highly preferred).
• Experience working with infectious disease programs and large-molecule development (highly preferred).
• Experience qualifying, validating, or executing analytical methods within a QC laboratory (highly preferred).