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 | Job posted by U.S. Engineering Technical Services, inc |
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| Description | The Manager/Sr Manager QA will be responsible for providing leadership and technical management for the Quality Assurance function, including Compliance and Quality Systems. The role may be expanded to include QA Documentation. The candidate must have demonstrated experience in biologics manufacturing processes, technical investigation review and world-wide regulatory compliance requirements. This person will evaluate and enhance, as needed, the company Quality Systems to ensure that internal processes meet defined quality standards and comply with the appropriate cGMP guidelines. Responsibilities Oversee and plan QA compliance activities and provide technical expertise. Establish and maintain positive working relationships and network effectively across all departments to ensure a culture of quality throughout the organization. Manage service-related production record review. Lead QA efforts to disposition all raw materials and product contact disposable products, drug products, components, raw materials, in-process materials, packaging and labeling. Manage the change control, deviations, CAPA and investigation processes. Evaluate, propose and implement new methodologies or technologies as alternatives to optimize efficiencies in the facilities, processes and programs. Participate in and approve risk assessments. Establish quality metrics and manage regular assessments against metrics followed by implementation of any needed changes. Develop and maintain appropriate controls around protocols and procedures, control forms, investigations, and other controlled documents as needed. Train and supervise all staff in cGMP and quality system procedures. Manage the Quality Assurance responsibilities of delivering FlexFactories to customers Prepare staff for and support regulatory agency inspections and client quality audits. Drive internal and external audits to ensure continual compliance. |
| Requirements | Supervisory Responsibilities Oversee Quality Assurance Compliance team; may also lead QA Documentation in the future. Minimum Qualifications Bachelor's Degree, with scientific background preferred; advanced degree a plus. 10 years of experience in QA in a GMP Manufacturing Facility; minimum 5 years of management experience. Experience with single use manufacturing technologies or products a plus. Proven record of successfully managing a QA department in a pharmaceutical/biotech environment. Vast knowledge of the fundamentals of QA management in the Biotechnology/Pharmaceutical fields throughout the product life cycle and hands-on technical expertise is required. Thorough knowledge of both US and international regulations related to biopharmaceutical industry, including clinical manufacturing of bulk drug substance, is essential Ability to apply GMP principles in US and EU clinical production a must Experience in a graduated approach to cGMPs based on the regulatory maturity of the product. Experience with quality management from early development through pre-approval and biennial inspections. Travel requirements expected to be =20% |
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This job expired on 10/02/2012
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