Manage organizational quality with established SOPs and processes (Deviations/Investigation, CAPA, Quality/Operational Risk Management, Change Control, Quality Metrics, Internal Audits, External Vendor Audits, and Inspection Readiness)
Manage the Inspection Readiness Program and oversee the execution of regulatory audits and tracking of responses to ensure progress. Compiles all regulatory inspection observations/findings and monitor for signals and trends.
Assist in the management and logistics of third-party inspection related activities.
Manage the Internal and External Audit Schedules/Programs and oversee the execution of the remediation responses to ensure progress. Compiles all audit findings and monitor for signals and trends.
Manage the Vendor Management System, which includes the vendor approval and qualification process, maintenance of the Approved Vendor List, and oversee the management for creation/response to vendor questionnaires.
Quality Operations Management
Oversee Quality Operations (incoming inspection, in-process testing).
Reporting and Metrics
Drive consistent reporting of appropriate Quality Management System and other applicable metrics.
Establish and monitor quality metrics for GMP related functional areas within the organization. Issue monthly reports. Escalates significant issues to executive management, as required.
Quality Issue Resolution and Communication
Identify quality issues/discrepancies, and effectively and proactively resolve them in a diplomatic, flexible, and constructive manner.
Promote a quality mindset within Quality and throughout RK Pharma by ensuring consistent, risk-based, and innovative thought processes are employed to advise and make decisions.
Communicate milestones and planned changes to the user community regarding Quality System and Compliance initiatives.
Team Management and Training
Provide operational management for the functional team.
Train team members and/or coordinate training for the facility including but not limited to annual cGMP training.