Aseptic Product Quality Manager

Job Title: Aseptic Product Quality Manager

Location: Rochester, NY (Hybrid)

Duration: 12+ Months

Job Summary:

Seeking an experienced Aseptic Product Quality Manager to provide Quality SME support for aseptic manufacturing, investigations, product transfers, and external manufacturing operations.

Key Responsibilities:

• Lead Quality activities for aseptic manufacturing and third-party manufacturing operations.
• Support aseptic event investigations, risk assessments, root-cause analysis, and CAPA.
• Drive implementation of aseptic manufacturing best practices and continuous improvement.
• Support final product lot release and product quality decisions.
• Manage Quality and Technical Agreements and ensure compliance commitments are met.
• Support audits, site approvals, due diligence, and regulatory inspection readiness.
• Lead Quality activities for product launches and manufacturing transfers.
• Review quality trends, deviations, CAPA, APR/APQR, and management-review activities.
• Partner with Quality, Manufacturing, R&D, Regulatory, and external manufacturing teams.

Qualifications:

• Bachelor's degree in Life Sciences, Engineering, Pharmaceutical Sciences, or related field.
• 5+ years of experience, including 5+ years in Quality Assurance and/or aseptic manufacturing.
• Strong knowledge of aseptic manufacturing, cGMP/GxP, quality systems, investigations, CAPA, and risk management.
• Experience with pharmaceutical, biological, sterile, liquid, solid, or medical device products preferred.
• Strong analytical, problem-solving, communication, and cross-functional leadership skills.