Karyopharm Therapeutics Inc. Associate Director/Director, GXP Auditing in Newton, Massachusetts
The Associate Director, GXP Auditing is responsible for the management of all activities related to the successful operation of the global internal and external GXP audit program.
• Development and management of an effective risk-based internal and external GXP audit programs
• Manage the development, implementation, and maintenance of standard operating procedures (SOPs), work instructions (WIs), checklist and templates that govern the internal, external, and GXP vendor audit program.
• Create annual internal and external audit schedules, assign responsibilities to the audit team members, and ensure audits are performed according to the audit schedule.
• Select and oversee contract auditors.
• Provide training to the audit team members and conduct co-audits, as required.
• Conduct internal and external audits, as needed.
• Review audit reports to ensure they are clear and cover the most important information to support successful development of corrective and preventive actions (CAPAs).
• Identify key performance indicators (KPIs) and metrics for the audit program to ensure compliance with SOPs/WIs, applicable regulations/standards, and continuous improvement.
• Support vendor qualification activities including the review of questionnaires and other applicable documentation to support the assessment of vendors. Escalate critical findings to the Head of Quality.
• Ensure the approved vendor list (AVL) is maintained and inspection ready at all times.
• Drive closure of CAPA resulting from audits, as needed.
• Assist in inspection readiness activities.
• Participate in regulatory audits, PAI readiness audits and inspections as directed by QA Management.
• Participate in Quality team projects, programs, and initiatives, as required.
• Up to 30% travel, domestic and international required.
• BS / MS in a scientific or engineering discipline
• 8-10 years of Quality Assurance experience in pharmaceutical / biotech industry, with a minimum of 5 years GXP audits experience executing audits.
• Thorough working knowledge of Regulatory Compliance, Quality System Management and Quality Assurance principles and practices.
• Knowledge of FDA and EU cGXP requirements.
• Expert knowledge of GCP and GMP regulations and standards.
• Ability to write and revise documents.
• Ability to use judgment in situations for which there are no precedents.
• Outstanding communication skills (verbal and written)
• Ability to manage multiple projects in a fast-paced environment
• Ability to effectively collaborate in a dynamic, cross-functional matrix environment.
Karyopharm Therapeutics is a commercial-stage pharmaceutical company focused on the discovery development, and commercialization of novel first in-class drugs directed against nuclear transport and related targets for the treatment of cancer and other major diseases.
Street: 85 Wells Ave.