Head of Quality & Pharmacovigilance Compliance <\/p>\n
Location: United States (Remote \/ Hybrid)<\/p>\n
Travel: ~10%<\/p>\n
Compensation: Base salary $180,000 \u2013 $240,000, +bonus<\/p>\n
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About the Company<\/p>\n
Global commercial pharmacovigilance product, \u00a0Tuberous Sclerosis Complex (TSC) U.S. affiliate, the company operates with a lean internal structure, leveraging best\u2011<\/span>in\u2011<\/span>class external vendors and consultants while maintaining strong internal governance and regulatory oversight.<\/p>\n Seeks Head of Quality & Pharmacovigilance Compliance<\/strong> serves as the company\u2019s senior U.S. authority for Pharmacovigilance (PV), Quality, and Compliance. This role provides enterprise\u2011<\/span>level oversight and governance to ensure regulatory compliance, inspection readiness, and effective risk management across U.S. regulatory domains.<\/p>\n This is a strategic leadership role, accountable for system ownership, risk visibility, and inspection readiness, while day\u2011<\/span>to\u2011<\/span>day execution is performed by functional teams and external partners.<\/p>\n <\/p>\n Key Responsibilities<\/strong><\/p>\n 1. Enterprise Compliance Oversight & Risk Visibility<\/p>\n <\/p>\n Serve as the accountable owner of the U.S. compliance framework across PV and Quality domains.<\/p>\n Maintain a consolidated, enterprise\u2011<\/span>level view of compliance status, risks, and mitigation activities.<\/p>\n Identify, document, monitor, and escalate material compliance risks.<\/p>\n Advise the CEO and executive leadership on compliance risk exposure, trends, and inspection readiness.<\/p>\n Prepare and present regular compliance and risk updates to executive management.<\/p>\n Review and formally approve compliance\u2011<\/span>related documentation for accuracy, completeness, and regulatory alignment.<\/p>\n Provide readiness confirmation for documents requiring executive signature (legal responsibility remains with officers).<\/p>\n <\/p>\n <\/p>\n 2. Quality Management System Oversight (Non<\/strong>\u2011<\/strong>PV)<\/strong><\/p>\n <\/p>\n Oversee adherence to Quality Assurance SOPs and processes outside of Pharmacovigilance.<\/p>\n Act as the internal Quality authority, partnering with external QA consultants.<\/p>\n Review audit findings, quality metrics, and compliance reports.<\/p>\n Require and track corrective actions, confirming ownership and timelines with functional leaders.<\/p>\n Escalate unresolved quality or compliance issues as appropriate.<\/p>\n Ensure consistent application of quality governance, documentation, and reporting standards across functions.<\/p>\n <\/p>\n <\/p>\n 3. Pharmacovigilance Quality System Ownership & Inspection Readiness<\/strong><\/p>\n <\/p>\n Serve as the formal owner of the U.S. post\u2011<\/span>marketing Pharmacovigilance Quality System, including:<\/p>\n <\/p>\n PV SOP governance<\/p>\n Deviations and CAPAs<\/p>\n Training oversight<\/p>\n Documentation and record readiness<\/p>\n <\/p>\n <\/p>\n Drive adherence to PV SOPs through oversight and monitoring of internal teams and external PV vendors.<\/p>\n Oversee PV vendor performance related to adverse event intake, case processing, complaints, and regulatory submissions.<\/p>\n Review key safety deliverables (e.g., PADERs, DSURs) to ensure quality and regulatory compliance.<\/p>\n Lead and coordinate FDA inspections, regulatory interactions, and PV\u2011<\/span>related audits.<\/p>\n Maintain continuous inspection readiness through periodic reviews of PV processes, records, training, and vendor performance.<\/p>\n <\/p>\n <\/p>\n 4. Training & Compliance Culture<\/strong><\/p>\n <\/p>\n Oversee the design and effectiveness of role\u2011<\/span>based Quality and Pharmacovigilance compliance training.<\/p>\n Promote a strong compliance and quality culture across the organization.<\/p>\n Serve as a key escalation point for compliance questions, concerns, and potential issues.<\/p>\n <\/p>\n <\/p>\n Required Qualifications (Must<\/strong>\u2011<\/strong>Have)<\/strong><\/p>\n <\/p>\n 6+ years of experience in Pharmacovigilance, PV Quality, or Quality \/ Compliance roles within the pharmaceutical or life sciences industry.<\/p>\n Direct experience with U.S. post\u2011<\/span>marketing Pharmacovigilance.<\/p>\n Proven experience owning or governing a Pharmacovigilance Quality System, including SOPs, deviations, CAPAs, training, and vendor oversight.<\/p>\n Experience supporting or leading FDA inspections or PV\u2011<\/span>related audits.<\/p>\n Strong understanding of PV regulatory requirements and inspection expectations.<\/p>\n Demonstrated ability to operate effectively in a lean organization with extensive vendor reliance.<\/p>\n Ability to communicate complex regulatory topics clearly to executive and non\u2011<\/span>specialist audiences.<\/p>\n <\/p>\n <\/p>\n Preferred Qualifications<\/strong><\/p>\n <\/p>\n Exposure to broader Quality or Compliance areas beyond PV (e.g., GxP, DSCSA, Medical Information \/ OPDP).<\/p>\n Experience coordinating and governing external vendors or consultants.<\/p>\n Prior experience in small or mid\u2011<\/span>sized pharma \/ biotech organizations.<\/p>\n Interest in expanding scope from PV\u2011<\/span>focused leadership to enterprise\u2011<\/span>wide Quality & Compliance oversight.<\/p>\n <\/p>\n <\/p>\n Why Join Us<\/p>\n <\/p>\n First U.S. product launch with high visibility and impact<\/p>\n True system ownership and executive influence<\/p>\n Clear separation between governance and execution<\/p>\n Opportunity to shape the Quality and PV compliance function from an enterprise perspective<\/p>\n <\/p>\n <\/p>\n