Head of Quality and Pharmacovigilance Compliance

Nobelpharma America Recruiting TeamBethesda, MD
23d$180,000 - $240,000

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. Base Salary range is $180,000 to $240,000, commensurate with qualifications and experience.

Requirements

  • Bachelor’s degree in business, marketing or life sciences preferred.
  • Minimum of 7 years' experience in the pharmaceutical/biotech/life-sciences industry.
  • Understanding of FDA/PhRMA promotional requirements.
  • Knowledge of reimbursement and access issues.
  • Strong verbal, written, and presentation skills.
  • Overnight travel required (60–70%).
  • Strong strategic thinking and execution capability required.

Nice To Haves

  • Experience in rare disease, dermatology, or neurology preferred.
  • Experience handling rare disease therapeutic products is strongly preferred.

Responsibilities

  • Enterprise Compliance Oversight & Risk Visibility
  • Oversight of Other Quality Assurance Areas (Non-PV)
  • Pharmacovigilance Quality & Inspection Readiness
  • Training and Compliance Culture
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