Quality Assurance Manager

Job Title: Aseptic Shop floor Product Quality Manager

Duration: 1-Year Contract

Location: Rochester, NY (Monday–Friday, Standard Business Hours) Hybrid role 3 days onsite

The Aseptic Product Quality Manager acts as a quality SME for aseptic manufacturing within the External Product Quality Assurance Eye Care Global Team. The position is responsible for supporting aseptic events within the Eye Care Quality Assurance Third Party Manufactures (TPM) team by providing hands-on assessments and investigation support. The Global Quality Manager will drive implementation and aseptic best practices at TPM based on company standards and technological advancements.

The Global Quality Manager will work effectively with TPM by promoting improvements that proactively identify, quantify, prioritize, and mitigate aseptic risks. Global Quality Manager will also establish collaborative relationships with internal sites, aseptic global team, and cross functional teams.

• Maintains the primary quality lead with management oversight for project activities and the team members (within and outside of the company) to achieve on-time quality deliverables, high customer value, and profitable results. Primary driver for the quality and compliance aspects of product transfers and organization optimization.
• Provides Eye Care Quality Assurance Third Party Manufactures (TPM) team support for investigation for aseptic events by providing hands-on assessments and investigation support.
• Drives implementation and aseptic best practices at TPM based on company standards and technological advancements.
• Performs final quality release of manufactured product lots for products and/or product lines prepared by Third Party Manufacturers.
• Makes recommendations for key decisions on product quality and compliance and regulatory conformance issues for sterile, biological, liquid, solids, and/or device products and elevates medium and high risk events to management. Ensures alignment of Quality and Technical Agreements with the legal contracts and that the commitments of the quality and technical agreements are being fulfilled. Helps facilitate resolution in cases where they are not.
• Establishes and maintains relationships and open communication with Third Party Manufacturers, plants, affiliates and other functional groups to maintain roles and responsibilities, identify potential projects and issues, obtain an in-depth understanding of the quality, compliance, and resource needs at each site and provide guidance on quality concerns.
• Communicates and negotiates with external companies’ quality organization to maintain a consistent level of quality and a level of expectation that will minimize compliance risks but also balance the cost of operating to provide the agreed service. Prioritizes programs, initiatives, and problem solving with consideration for impact to timelines, resources and conflicting priorities.
• Interfaces with Quality Assurance audit team to develop audit plans, due diligence plans, and inspection readiness plans, review audit observations and responses, and maintain corrective action timetable. Provides support for quality audits, initial site approvals and due diligence activities. Leads and manages pre-approval inspection readiness as related to the third party manufacturers to ensure regulatory approvals are obtained, with no delays to market entries.
• Contributes to Quality Assurance elements needed to facilitate new product launches including Third Party Manufacturer’s that provide products directly to distribution centers, or to domestic and International plants for further packaging and/or testing. Coordinates activities to support follow-up on compliant trend investigations for non-medical…