Role summarydirector, gmp and quality systems compliance, reporting to the senior director, quality assurance, responsible for leading and overseeing compliance across gmp and quality systems. Establish procedural and system requirements for supplier and contract service provider quality management, maintain inspection readiness across the clinical and future commercial network, develop regulatory intelligence, oversee internal audits and self-assessments, and coordinate annual quality system reviews including qmr and annual product reviews after commercial launch. Based in cambridge, ma or san francisco, ca with up to 25% travel.responsibilitiessupplier / contract service provider quality managementpartner with regulated business functions to identify suppliers and csps requiring quality and compliance oversightestablish assessment mechanisms, risk-based controls, and monitoring and feedback loops for compliant oversightserve as a resource for audits and other assessments, internally and externallyinspection readiness and compliance infrastructureestablish and maintain infrastructure and processes to prepare olema and partners for inspections by u.s. and international regulatorsutilize electronic systems, including ai-enabled tools, to support inspection readiness activitiesdeploy and maintain inspection management software for consistent inspection preparation and responseregulatory intelligence and monitoringcreate and maintain regulatory intelligence focusing on inspectorate enforcement trends to support accelerated product developmentmonitor inspection status and compliance trends within the supplier and csp networkapply generative ai tools to support monitoring and interpretation of regulatory trends and outcomesinternal compliance risk identification and quality improvementdevelop minimally disruptive methods to identify internal compliance risks and opportunities related to quality, efficiency, and effectivenesscollaborate with internal partners to build commitment around implementing opportunities for improvementguide quality and regulated functions to meet annual quality system commitments as olema approaches commercial operationsannual reviews and quality system leadershiplead and coordinate the annual quality management review processoversee preparation and execution of annual product quality reviews upon commercial product launchcollaborate with quality systems to plan and deliver annual gxp topical training for relevant functionsadditional responsibilitiesdeploy inspection management software and train usersuse and train others in ai toolsets for quality and compliance operationsadvise cross-functional partners on risk-appropriate deployment of additional quality and gmp technologiesperform audits and execute supplier or csp questionnairesprocess supplier corrective action requests (scars) and external change notifications (ecns)qualificationsbachelor's degree in biology or a related scientific fieldstrong understanding of u.s., eu, california, and rest-of-world (row) regulatory and compliance requirementsdemonstrated experience in supplier compliance and inspection managementfirm knowledge of gmps and quality management systemsexperience using inspection management softwareminimum 15 years of experience in biopharmaceutical industryminimum 10 years of experience in supplier quality managementexperience with oral solid dosage formspharmaceutical auditor certification is highly preferredoncology experience is preferredpeople management or leadership experience is desirable for overseeing contract resources and growthself-directed, able to set and manage prioritiesadaptable to rapid organizational change and evolving processesrisk-based approach to quality and compliance with focus on business and patient impactstrong cross-functional partnership, collaboration, and communication skillscomfort with adopting and tailoring new technologies to quality and compliance needsteam-oriented with a focus on delivering meaningful impactpassionate about contributing to patient-focused outcomes
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