Bachelor's Degree in a relevant Life Science or related technical field or equivalent experience.
7+ years of total experience, with a minimum of 5 years in Quality Assurance/Aseptic Manufacturing and 3 years in Operations or R&D.
Comprehensive understanding of aseptic manufacturing and biological/pharmaceutical technologies including various product forms.
Strong analytical, problem-solving, and interpersonal skills necessary for managing complexities and urgency.
Responsibilities
Oversee project activities and team members to ensure quality deliverables and customer satisfaction.
Lead quality and compliance for product transfers and organizational optimization.
Support investigation of aseptic events within the Eye Care Quality Assurance TPM team.
Implement best practices for aseptic processes at Third Party Manufacturers according to company standards.
Approve final quality releases for products manufactured by Third Party Manufacturers.
Advise on key product quality and compliance decisions, coordinating with management on risks.
Ensure alignment of Quality and Technical Agreements with legal standards and facilitate resolutions.
Benefits
Opportunity to work with cutting-edge technologies in quality assurance.
Engage in high-impact projects that improve customer satisfaction and operational efficiencies.
Access to continual professional development and training opportunities.
Full Job Description
Responsibilities:
Maintains the primary quality lead with management oversight for project activities and the team members (within and outside of Client) 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 Client's 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 Client 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, Client 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 Client with 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 Client domestic and International plants for further packaging and/or testing.
Coordinates activities to support follow-up on compliant trend investigations for non-medical and medical (adverse events). Supports the management of exception documents and Corrective and Preventive Actions.
Completes management reviews with assigned Third Party Manufacturers that identify and address quality, operational, and organizational issues.
Obtains and reviews summaries of the Annual Product Reviews (domestic) and Annual Product Quality Reports (EU) from the Third Party Manufacturer to ensure accuracy, completeness, timeliness, and trends are identified and addressed in an appropriate manner.
Qualifications:
Bachelor's Degree in relevant Life Science or other technical discipline or equivalent job experience required.
7+ years of total combined experience. At least 5 years in Quality Assurance/Aseptic Manufacturing Operations Management; 3 years in Operations, Research and Development or Consulting.
Knowledge and comprehensive understanding of aseptic manufacturing and 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).
Possesses 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, and capable of performing as leaders, members and individuals.
