Aseptic Product Quality Manager
Listed on 2026-09-05
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Quality Assurance - QA/QC
Production QC/QA, Quality Control - QC Analysts/Managers, Regulatory Compliance Specialist, Quality Engineering -
Manufacturing / Production
Production QC/QA, Regulatory Compliance Specialist, Quality Engineering
Aseptic Product Quality Manager
Pay Range: $75 to $80 per hour
Client Industry: Pharmaceutical
Job Mode:
Hybrid — majority onsite at manufacturing site.
Contract Duration: 12 Months (Possible Extension Based on Performance and Business Needs)
Job Summary:
The Aseptic Product Quality Manager will provide Quality leadership and technical oversight for aseptic manufacturing operations at an external manufacturing site. The role will provide hands on Quality assessments, investigation support, and guidance for GMP manufacturing activities. The position will drive aseptic best practices, identify and mitigate manufacturing risks, and support product quality and compliance decisions. The role requires strong leadership, analytical, and problem solving skills while working closely with external manufacturing and cross functional teams.
- Provide Quality oversight for aseptic manufacturing operations at an external manufacturing site.
- Serve as a Quality leader and technical resource for manufacturing activities. Conduct hands on assessments and support investigations related to aseptic events.
- Drive implementation of aseptic manufacturing best practices.
- Support final Quality release of manufactured product lots.
- Evaluate product quality, compliance, and regulatory issues and escalate higher risk matters appropriately.
- Review manufacturing documentation, PPQs, certifications, investigations, CAPAs, exceptions, and product quality records.
- Work with external manufacturing partners to identify, prioritize, and mitigate Quality and compliance risks.
- Support Quality audits, inspection readiness, due diligence, and regulatory activities.
- Support product launches, manufacturing transfers, and related Quality activities.
- Review product quality reports and manufacturing trends and ensure identified issues are appropriately addressed.
- Collaborate with Quality, manufacturing, technical, and cross functional teams to resolve complex issues.
- Bachelor's degree in Life Sciences, a technical discipline, or equivalent experience.
- 5 or more years of Quality Assurance or Aseptic Manufacturing Operations Management experience.
- Hands on manufacturing site or shop floor Quality experience.
- Strong knowledge of aseptic manufacturing and GMP pharmaceutical or biological manufacturing.
- Experience overseeing GMP manufacturing activities such as filling, packaging, compounding, or similar operations.
- Strong analytical and problem solving skills with demonstrated leadership and management experience.
- Ability to manage multiple complex priorities in a high urgency manufacturing environment.
- Ability to work primarily onsite in Rochester, NY.
- Experience with third party manufacturers, CMO or CDMO environments.
- Sterile pharmaceutical manufacturing experience.
- Biologics manufacturing experience.
- Sterile injectable manufacturing experience.
- Vaccine manufacturing experience.
- Ophthalmic or eye care manufacturing experience.
- Experience with Quality and Technical Agreements, inspection readiness, product quality reviews, and manufacturing transfers.
Benefits:
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, paid holidays annually - As Applicable
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