Is the site’s Quality Head and is responsible for implementation and management of site’s compliance to domestic and international GxP regulations, cGMP’s, and company policies. Assumes lead role in customer and regulatory audits. Is responsible for leading and developing QA staff and ensures QA resources are deployed and managed effectively. Is the owner of all Quality systems and Quality oversight in support of plant operations including the following:
- Quality Management Systems: Overall supervision of the elements of the site’s quality management system and to work with site personnel to ensure compliance to system elements.
- Product Release: Review and release or rejection of all raw materials, packaging components, intermediates, and finished goods.
- Document Management: Ensure systems are effectively in place to control and manage documents at the site.
- Deviation Management: Quality Assurance oversight of Deviation Management system.
- Technical Complaint Management: Investigation, documentation and approval of technical complaints and adverse events. (Adverse events at the request of Drug Safety)
- Annual Product Review Management: Annual Product Review document creation.
- Customer Relationship Management: Manage customer quality agreements, keep current and ensure business activities are in alignment with the terms of the QAA.
Job Result Areas:
- Safe, Effective Products
- Effective, Efficient Quality System
- Skills & Performance of People Are Appropriate for Business Needs
- Investigations Reach Sound Conclusions and CAPA’s are Identified
- Quality Guidance & Advice
Minimum 10 years of experience in FDA regulated environment. Experience in Quality Assurance Management position in manufacturing, facility operation, laboratory compliance and quality systems. Previous supervisory experience required. Experience interacting with regulatory authorities.
Bachelor's Degree in Biology, Chemistry, Pharmacy or related field required, Master's Degree preferred.
Strong leadership characteristic with the ability to be a transformative change agent. Ability to influence individuals throughout the organization. Comprehensive understanding of current regulatory requirements and ability to interpret them. Experience in audits and regulatory inspections (FDA & others).Strong knowledge of GxPs and their application. Knowledge of both U.S. and international regulatory requirements/guidance and development standards. Ability to analyze complex situations and processes.