Job Posting: Product Quality Representative
Position serves as direct customer interface for product technical questions, investigations, CAPA, change controls, and complaints. Position provides CAPA system oversight of other departments and ensures change controls, complaints and investigations are compliant with cGMP, as well as other global regulatory requirements and expectations. Position is responsible for review of or authoring of change controls, complaint investigations, nonconformance investigations, laboratory OOS investigations and environmental monitoring excursions.Specific Responsibilities
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.
Provide investigations and change controls to customers for QA and regulatory review and approval.
Work with customers, as well as directly with vendors to resolve/address quality issues
Provide guidance and direction to all departments regarding investigations and appropriate CAPA.
Provide Quality input / guidance regarding development of manufacturing controls, specifications, and regulatory requirements for new products and/or manufacturing processesRequirements
- MS in a technical or scientific discipline (i.e. Chemistry, Biology or Biochemistry) or BS and commensurate experience.
- Minimum 4 years pharmaceutical industry experience required, in a technical or Quality role, with previous experience in regulatory, complaint handling, and investigation/CAPA activities
- Broad 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 proven ability and skill 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
At Exelead, we approach contract manufacturing with focused expertise on liposomal and PEGylated formulations to treat rare diseases and small or underserved populations. We specialize in the development and manufacture of lipid-based, parenteral drug products, and our team has more than 20 years' experience working with a wide range of preclinical, clinical and commercial customers.