The Associate Director, RQA is responsible for quality oversight of all Analytical Development activities. Oversight includes ensuring compliant quality systems used to support development and testing of clinical supplies such as the Deviation System, Change Control, Laboratory Investigations, Stability, Specifications, Equipment Qualification and Calibration. The Associate Director RQA is also responsible for working within the quality systems to review and approve Analytical Sciences laboratory and GMP investigations, protocols, Specifications, Test Methods, and SOP's. In addition, the associate director approves regulatory submission documents, site transfer documents, and new product documents, including IND and NDA CMC submissions. This role is also responsible for the development and maintenance of departmental SOP's and processes as assigned. As part of continuous improvement, the Associate Director RQA will initiate Quality System process improvements via the initiation of new processes or the improvement of existing processes.
Specific responsibilities include:
Educational Requirements A minimum of a BS in the physical sciences and a minimum of 10 years pharmaceutical related experience within Laboratory, Production, and/or Quality Management and/or Research QA.
- Providing oversight for all Quality Systems governing Analytical Development activities such as Deviation Management, Laboratory Investigations, Planned deviations, CAPA, Stability, Specifications, Laboratory Equipment Qualification/Calibration and Reference Standard management. - Providing oversight for the R&D Documentation system including system administration and coordination of the document management system QDCS, site Good Documentation Practices, site documentation storage and archival vault functions, notebook and master batch record issuance, and ownership of the LibertyNet laboratory notebook storage system. - Monitoring of assigned Quality Systems, generating metrics and presenting metrics and system risks to management on a periodic basis - Review and approval of documentation such as investigation, methods, method validations, planned deviations, CAPA, Certificates of Analysis - Reviewing and approving change controls - Reviewing and approving equipment qualification protocols and reports and oversight of the calibration program - Verification of source data and review of IND/NDA CMC sections for regulatory filings - Coordination of required periodic reviews of US Pharmacopoeia updates across all Purdue sites and leadership/management of the program as program owner - Assessment of analytical lab notebooks and data which requires an understanding of chromatographic data, analytical lab troubleshooting, and the ability to evaluate laboratory conclusions for relevance to experimentation - Oversight of the Research Stability program - Participation on Non-Clinical Development Teams - Authoring of Standard Operating Procedures and conducting training - Supervising daily activities of employees - Facilitating the Research Quality Assurance internal audit program and hosting internal corporate audits - Manage the commercial Quality Standards process for the creation, revision and approval of all product specifications - Chair Purdue's Specification Committee for commercial product and participate on the R&D API specification committee for API in early phase development - Manage Purdue's Compendial Compliance Program
Required Experience & Technical Requirements
Incumbent must have:
- A thorough understanding of analytical laboratory quality systems and an excellent working knowledge of CGMP, DEA, ICH, and FDA regulations. - Possess good technical writing skills to be used in evaluating documents and writing SOPs and other associated documentation. - Possess a strong ability to resolve and communicate technical issues, and perform root cause analysis. - Experience supervising staff preferred. - Hands on experience in the following computer software programs: Windows, MS Word, Excel, Outlook, and PowerPoint.
Morolake Esi Recruiter
Purdue Pharma - 23 months ago