Product Quality Senior Manager (Science)
$124,500–$236,500 year
HybridNorth Chicago, Illinois, United States
Job Summary
Maintain the primary quality lead for product transfers and organization optimization across small molecule, biologic, and medical device portfolios. Develop global Product Quality Assurance strategy and perform final quality release of lots from third-party manufacturers. Make key decisions on regulatory conformance for sterile and biological products, elevating high-risk events to management. Establish relationships with external quality organizations to negotiate service levels and minimize compliance risks while balancing costs. Lead pre-approval inspection readiness for third-party manufacturers and manage audit plans, due diligence, and corrective action timetables. Facilitate new product launches and coordinate trend investigations for adverse events. Complete management reviews with manufacturers to address operational issues and review Annual Product Quality Reports. Requires 8+ years of experience with a background in Quality Assurance Operations Management and direct manufacturing plant experience.
Required Qualifications
- Bachelor's Degree in relevant Life Science, Engineering, or other technical discipline
- Minimum 8+ years total combined years of experience
- At least 3 years in Quality Assurance Operations Management
- 5+ years in any of the following areas: Operations, Research and Development, Regulatory or Consulting
- Direct Manufacturing Plant experience in a Pharmaceutical setting
- Strong quality assurance/control background
- Manufacturing background
- Laboratory background
- Technical support background
- Regulatory background
- Validation background
- Experience with FDA and other regulatory agency interactions and inspections
- Knowledge and a comprehensive understanding/expertise of some biological and/or pharmaceutical technologies (sterile, biological, liquid, ointments, devices, solid tablets and caplets, suspensions, granulations, soft elastic capsules, gel caps, extended release products, coating solutions, and/or active pharmaceutical ingredients)
- Knowledge and a skill set to operate within an environment that requires a high degree of urgency
- Strong analytical and problem solving skills
- Positive interpersonal skills
- Ability to manage multiple complex tasks simultaneously
- Capable of performing as leaders, members and individuals
Desired Qualifications
- Direct Manufacturing Plant experience in a Pharmaceutical setting
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