Senior Manager, GxP Audit Program

Full Time Remote in United States Finance Manager Audit Apply for this Job Responsibilities

• Support development, maintenance, and implementation an annual GxP audit plan in coordination with leadership with all GxP functional areas
• Manage contracts with providers of contracted GxP auditing services and carefully manage associated budgets; oversee assignment of audits to contracted auditors for the timely completion of audit plans
• Select, train, and oversee external auditors; monitor auditor performance and maintain external auditor training curriculum, records, CVs, etc.
• Work with the business leads to oversee the development of audit agendas designed to effectively asses auditee risk areas
• Lead internal GxP audits; provide training/direction to support auditors to facilitate internal audit capabilities within Karyopharm
• Lead high-priority external GxP audits and due diligence assessments as needed
• Schedule audits with external auditors per audit plan
• Schedule and facilitate pre-/post-audit meetings w/key stakeholders; manage completion of action items
• Assure audit project folders are prepared/maintained in Egnyte and manage access for designated users
• Evaluate and escalate potential critical observations and/or potential Unsatisfactory audit outcomes from contract auditors; prepare summary of available facts and initial analysis for senior management review
• Review audit reports to ensure they are clear and cover the most important information to support efficient development of meaningful CAPAs; confirm accuracy of standards cited and factual support for observations to justify classifications & ratings
• Prepare audit performance metrics to assure audit program is conducted per standards and SOPs
• Perform audit trending of audit findings to assist QA and organization in identifying potential risks and supporting continuous improvement
• Assure all audit plans, reports, CAPAs and certificates are appropriately archived
• Support supplier qualification activities including review of questionnaires and vendor approvals
• Evaluate Audit and Inspection Program processes for continuous improvement opportunities
• Support Karyopharm GxP Quality System projects, programs and functional area initiatives as required
• Support ongoing inspection readiness activities
• Up to 10% domestic and international travel required (for audit performance)

Qualifications

• Bachelor's degree in life sciences or engineering
• 10+ years of experience in the pharmaceutical or biotechnology (or similar) industry
• 7+ years GxP QA Audit and/or Regulatory Inspection management experience
• 3+ years’ experience as a GxP Lead Auditor
• Advanced knowledge and demonstrated experience in the applicable (e.g. FDA, EMA, WHO, ICH, etc.) GxP regulations, standards, guidelines, and expectations
• Advanced experience in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to subject protection and data integrity
• Advanced project management experience; ability to manage cross-functional teams
• Significant experience with QMS management and administration including eQMS systems
• Demonstrated ability to effectively organize and execute complex tasks
• Strong verbal and written communication (including presentation) and customer management skills