Head of Quality and Pharmacovigilance Compliance

Nobelpharma America Recruiting Team•Bethesda, MD

17h•Remote

About The Position

Nobelpharma America launched its first product in the U.S., indicated for Facial Angiofibroma associated with Tuberous Sclerosis Complex (TSC). The Head of Quality and Pharmacovigilance Compliance acts as the company’s senior authority for U.S. pharmacovigilance, compliance and quality matters, providing enterprise-level oversight to ensure clear governance, risk visibility, and adherence to applicable regulations and SOPs across regulatory domains. The role is accountable for maintaining a consolidated view of compliance status, identifying and escalating material risks, and advising executive management on compliance risk exposure and inspection readiness, while execution remains with functional teams and external partners. The role is responsible for the Quality Management System. In addition, the role serves as the formal owner of the U.S. post-marketing Pharmacovigilance Quality (PV-QA) system and is accountable for PV inspection readiness.

Requirements

6+ years of experience in Pharmacovigilance, PV Quality, or related Quality / Compliance roles within pharma or life sciences, including U.S. post-marketing PV
Strong understanding of PV Quality System governance, including SOP management, deviations, CAPAs, training oversight, and vendor compliance
Experience supporting FDA inspections or PV-related audits (preparation, response coordination, and follow-up)
Demonstrated ability to operate effectively in a lean organization, balancing governance responsibilities with pragmatic decision-making

Nice To Haves

Exposure to broader compliance or QA areas beyond PV (e.g., GXP, OPDP, DSCSA, state-level compliance)
Experience coordinating external vendors or consultants in a quality or compliance context
Interest in expanding scope from PV-focused leadership to enterprise-wide Compliance & QA oversight
Prior experience in small or mid-sized life sciences companies
Ability to communicate complex regulatory topics clearly to non-specialist audiences

Responsibilities

Serve as the accountable owner of the U.S. compliance framework, ensuring that compliance risks across regulatory domains are identified, documented, monitored, and appropriately mitigated.
Maintain a consolidated, enterprise-level view of compliance status, risks, and mitigation progress across U.S. regulatory areas, including but not limited to Medical Information / OPDP, DSCSA, and state-level compliance.
Act as a key advisor to the CEO and executive leadership by providing clear visibility into compliance risk exposure, trends, and inspection readiness.
Prepare and present regular updates to executive management on material compliance matter, risk assessments, and remediation activities.
Review and provide formal approval of compliance- and regulation-related documents to confirm they are complete, accurate, and aligned with applicable regulatory requirements and internal SOPs.
Provide formal readiness confirmation for documents requiring executive signature, while ultimate legal responsibility remains with company officers.
Coordinate with functional owners and external consultants to ensure accountability and timely remediation, without performing hands-on execution of operational tasks.
Oversee adherence to Quality Assurance SOPs and quality processes outside of Pharmacovigilance, acting as the internal counterpart to external Quality Assurance consultants.
Monitor compliance metrics, review audit findings and reports, and identify gaps or deviations from established quality standards.
Require corrective actions where deficiencies are identified, confirm ownership and timelines with functional leaders, and escalate unresolved issues as necessary.
Ensure that quality governance, documentation, and reporting practices are applied consistently across functions.
Serve as the formal owner of the U.S. Pharmacovigilance Quality System, including governance of PV SOPs, deviations, CAPAs, training, and documentation readiness.
Drive adherence to PV SOPs by internal teams and external vendors through oversight, guidance, and monitoring, while execution remains with responsible functions.
Lead and coordinate FDA inspections, regulatory interactions, and internal audits related to Pharmacovigilance quality.
Oversee PV vendors and adverse event and complaint case processing, including case quality, triage, and regulatory submission readiness.
Review key safety deliverables (e.g., PADERs, DSURs) to confirm quality, completeness, and regulatory compliance.
Maintain ongoing inspection readiness through periodic reviews of PV processes, records, training, and vendor performance.
Oversee the design and effectiveness of U.S. quality and pharmacovigilance compliance training programs, including role-based training requirements.
Promote a strong compliance culture by providing guidance and support to functional leaders and employees.
Serve as a key escalation point for compliance questions, concerns, or potential issues.