Job Posting: Product Quality Representative
Provides Quality Assurance leadership to the organization relative to product quality issues, new product introductions, and quality improvement opportunities for products and/or clients assigned. Acts as Quality System expert to the organization regarding design control. Coordinates activities that address quality issues with customers and regulatory agencies, both domestically and globally. Ensures the Indianapolis Manufacturing Facility (IMF) Quality Policy is understood, implemented and maintained in the organization. Performs quality planning to drive continuous improvements to the quality system that ensures ongoing effectiveness and efficiency.
This position is responsible for assembling individuals required for preparing / completing timely and thorough complaint and CAPA investigations and change controls, and actively participating in the preparation/approval of the investigations and change controls with customers. Position serves as direct customer interface for product technical questions, investigations, CAPA, change controls, and complaints. Position ensures change controls, complaints and investigations are compliant with CFR, FDA and ICH Guidances, global regulatory expectations, and international cGMPs. Position is responsible for oversight of QTS system for management of change controls, complaints, exceptions, issues and CAPAs.
Major Position Activities & Responsibilities
- Provide Quality Assurance expertise regarding product quality issues in order to ensure regulations and company standards are met (CFR, FDA and ICH, international cGMPs). Advice provided cross-functionally, to Supplier Quality and customers.
- Provide Quality Assurance leadership to others on appropriate use and implementation of Quality Assurance aspects of design control and commercialization process. Participate as member of various cross functional teams, as assigned to ensure QA principles are applied/ Quality System compliance is achieved. Develop strategy and lead implementation of quality and process control plans on product teams.
- Continually improve Quality System by investigating, developing and implementing permanent corrective and preventive actions for process/system failures. Assemble individuals required for preparing / completing timely and thorough investigations, and actively participating in preparing investigations. Collaborate, in a hands on manner, and provide direction on investigations and technical issues at the Indianapolis facility and at contract manufacturing sites
- Investigate, develop, review and/or propose disposition of non-conforming materials; review and approve of product and process change requests, provide investigations and change controls to customers for QA and regulatory review and approval.
- Interpret customer strategies into implementation plans for continual improvement in IMF activities; communicate IMF issues to customers; work with customers, as well as directly with vendors to resolve/address quality issues. Interact with stakeholders to drive quality issues to resolution.
- Analyze customer feedback data, formulate action plans to permanently resolve issues and assembles the appropriate technical resources required to drive the implementation of process and/or system improvements resulting in measurable improvement in product quality and/or customer perception.
- Supervise and lead site wide effort of designing, conducting, and writing investigations; provide guidance and direction to all departments regarding investigations and appropriate CAPA. Handle/investigate product complaints and provide quality oversight for product specific manufacturing operations.
- Provide Quality input and oversight to all departments, and customers, on product and process development projects. This includes validation initiatives and providing Quality input / guidance regarding manufacturing operations, process controls, specifications, and validation for new raw materials
- Support Quality Director in compiling and assessing stability data, validation study data, and development study data, as needed
- Provide Quality input / guidance regarding development of manufacturing controls, specifications, and regulatory requirements for new products and/or manufacturing processes
- As needed, compile data and author memos and reports that are submitted to customers and regulatory agencies in support of product licenses and applications
- Perform special projects and other duties as assigned.
- As a part of the employee’s job requirements, the employee may be required to handle wastes including hazardous wastes. The employee must attend mandatory annual hazardous waste training meeting(s) and show a competency in that training by passing test(s) administered by the company or consultant providing such training.
- Primary responsibility is guiding all IMF investigations, change controls, and complaints to ensure compliance with regulatory expectations, ensure thoroughness, and ensure effective CAPAs are implemented.
- Functions as a key technical resource in the Quality Operations organization and is technical expert on assigned product and related manufacturing operation.
- Responsible for notifying management and customers of major or critical product or process quality issues and changes
- Responsible for supporting management during regulatory inspections, e.g. providing details and rationale of IMF change controls, complaints, investigations.
- Responsible for providing notification of changes and investigations to customers and responding to customer requests for product/process information
- Does not have any direct reports.
- MS in a technical or scientific discipline (i.e. Chemistry, Biology or Biochemistry) or BS and commensurate experience.
- Pharmaceutical industry experience preferred, in a technical or Quality role
- Previous experience in regulatory, complaint handling, and investigation/CAPA activities
- Understanding of technical basis of products and processes and the relationship to product performance. Experience with sterile drug products and biopharmaceuticals preferred.
- Experience with FDA and EU GMPs, and ICH Guidance
- The position requires ability in analyzing, understanding, and presenting technical data both internally and externally to customers/inspectors/auditors.
- Excellent communication and writing skills; knowledge of electronic documentation tools/good documentation practices.
- Strong planning/organization/influencing skills, strategic perspective, leadership, initiative/self motivation, stress tolerance, team orientation, assertiveness, high ethical standards, results orientation.