Sr. Manager – Quality Compliance – CAR T Manufacturing

Sr. Manager – Quality Compliance – CAR T Manufacturing

Requirements

• Strong written and oral communication health authority communication skills; English language fluency.
• Strong problem-solving skills.
• Prior experience in a compliance role (e.g. Health Authority inspection management, inspection readiness, recall, Quality System remediation, QMS implementation, etc.).
• Prior experience interacting with FDA or other regulatory agencies.
• Ability to collaborate with personnel at all levels within and outside of the company.
• Strong knowledge of multi-country cGMP regulations (e.g. U.S, EMA, Japan).
• Proven experience working as a detail-oriented team player with effective planning, organization and execution skills.
• Innovative, proactive, and resourceful; committed to quality and continuous improvement.
• Ability to multitask and manage complex projects and timelines within a fast-paced environment.
• Ability to make independent and objective decisions, and to work with minimal supervision.
• Must be able to interact with and influence multidiscipline departments and CTO sites.
• Must possess an independent mindset and tenacity.
• Proficiency in developing reports and presentations to facilitate meaningful discussions, with clearly communicated analysis, findings, and impact.
• Excellent grammar and communication skills, both written and oral.
• Demonstrated proficiency in Microsoft Office applications.
• Bachelor’s degree required. An equivalent combination of higher education and experience is acceptable.
• A minimum of 6 years of industry experience.
• At least 3 years of direct health authority interaction experience.
• A minimum of 3 years of experience in Quality deviation.
• Strong experience with continuous improvement within quality and regulations.

Responsibilities

• Leads the Summit West (S12) Compliance team in the identification of Significant Events that may require a Notification to Management (NTM).
• Leads / Hosts Fact Finding meetings on behalf of S12 manufacturing for any Significant Events, including hosting the meeting, solving issues of significance, proposing a path forward, issuing minutes and ensuring all documentation is recorded in the Quality Management System.
• Issues Notifications to Management (NTM) for any Significant Events.
• Authors compliance reports to regulatory agencies, including, for example, Biological Product Deviation Reports to FDA (BPDRs), Product Defect Notifications to EMA or Drug Shortage Notifications.
• Communicates to site Senior Leadership Team regarding status of resolution, and interfaces with site external functions to drive resolution (e.g. Supplier Quality, Medical Affairs, Patient Safety, Regulatory Affairs, Global Quality Systems, etc.).
• Partners with Quality, Medical Affairs and Patient Safety to ensure completion of Integrated Health Hazard Assessments (IHHAs), when necessary.
• Ensures investigation of significant events are accurately communicated to the escalation team and apprises the escalation team of updates.
• Leads and coordinates critical compliance activities within S12 – including gap assessments, commitments, responses to audit and inspection findings, and ensures risks are properly mitigated.
• Participates in market recalls and mock recalls on behalf of S12.
• Collaborates with other relevant line functions to prepare and review regulatory submission documents, registration dossiers, and responses to health authorities, in scope of submission or periodic GMP review, upon request.
• Monitors compliance related processes (e.g. Product Quality Complaints, Notifications to Management, Mock Recall Assessments) to examine the overall health of the quality system in S12.
• Ensure site’s inspection readiness and prepares the site for regulatory (health authority) inspections, provide front room and back room support and be responsible for generating response documentation.
• Performs other Quality Compliance projects as required by management.

Preferred Qualifications

• Advanced degree preferred.
• Experience in CAR T or Biologics is preferred.
• Professional certification in Regulatory Affairs or quality certifications is desired.