Manager, GXP Systems
- Remote, Home Office, United States
- Department: Quality Assurance
Aurinia is a clinical stage biopharmaceutical company focused on developing and commercializing therapies in disease areas of high unmet medical need. We are currently developing voclosporin, an investigational drug, for the treatment of Lupus Nephritis (LN) and focal segmental glomerulosclerosis (FSGS). Additionally, we are advancing voclosporin ophthalmic solution (VOS), a topical formulation, for the treatment of dry eye syndrome (DES).
The incumbent will run and maintain the commercial Quality Management System (QMS) including audits, training, change controls, deviations, corrective and preventative actions, customer complaints, quality agreements, and vendor qualification. Responsible for QA oversight of GxP Computerized Systems and will ensure that computerized systems are suitably selected, validated, implemented, managed and system changes are handled appropriately.
• Reports to the Senior Director of Quality Assurance
• Approximately 10-20% travel is expected
• Manages all internal and external change controls, deviations, and investigations after consultation with the appropriate QA staff and reaches agreement with the relevant Aurinia departments. Chairs the Change Control Board meetings and ensures all action items are completed according to plan.
• Manages completed investigations and corrective and preventive action (CAPA) both internally and externally. Administers CAPA system to ensure CAPAs are closed and effective
• Manages all customer complaints for drug product and completes all trending and reports to meet reporting requirements
• Plans and conducts internal audits as described in the audit plan, including generating the audit report. Will support the completion of external audits as required.
• Manages all audit findings by directly liaising with the auditee to ensure all audits are closed out as per the agreed to timelines. Responsible for the maintenance of all audit documents, audit certificates, responses and finding close out.
• Oversees Aurinia’s document management process, including computer system storage of all appropriate quality documents, i.e. change controls, deviations, investigations, audit reports, complaint files, batch records, C of As, testing results, notes to file
• Participates in the Quality Management Committee as a subject matter expert.
• Oversees the electronic document management system, training record system and quality management system. Will determine regulations that are applicable to these computerized systems.
• Review and/or create Computer System Validation (CSV) documentation in collaboration with IT when appropriate.
• Maintains Master Batch Records (MBR), specifications, SOPs, forms, analytical methods and associated validation/transfer protocols.
• Reviews executed Batch Records (BRs) and releases material for clinical or commercial use. Liaise with Qualified person for European Union release.
• Acts as a QA lead with all departments to generate Management Reviews, Annual Product Reviews, and Site Quality Review
• Maintains up to date Quality Assurance Agreements (QAA) with vendors.
• Prepares and reviews Quality Assurance departmental procedures, policy documents, and memos when required.
• Provides GxP training to all staff, as required.
• Interacts with Aurinia’s Regulatory Affairs and supports regulatory submission preparation.
• Completes required Standard Operating Procedures (SOPs) training, as identified in training syllabus or job matrix.
• Follows approved policies and procedures as written.
• Attends all required training sessions and obtains a passing score.
• Ensures that the Quality Assurance department’s duties are carried out promptly, effectively and efficiently. • Other Duties as identified/assigned by management.
• University degree in science or college diploma, combined with a minimum of 8 years of relevant experience in the pharmaceutical industry. In-depth GxP knowledge and experience (Health Canada, FDA, EMEA)
• Minimum of three (3) years in a supervisory/management role
• Preferred three (3) years experience with software for QMS, DMS, or LIMS.
• Preferred three (3) years experience with Computer System Validation (CSV) with Good knowledge and understanding of international regulatory requirements such as 21 CFR Part 11 and GAMP5 guidelines, EU GMP Annex 11.
• Working knowledge of the different pharmacopoeias (USP, BP, EP, etc.)
• Excellent command of English language both written and spoken
• Knowledge of Microsoft applications
• Attention to detail and follow through
• Ability to work independently as well as in a team environment
• Motivated with an ability to make quick, informed decisions
• Well-organized, able to multi-task and coordinate several projects at once
All candidate information will be kept confidential according to EEO guidelines.