A leading specialty pharmaceutical company dedicated to bringing innovative treatments to patients with high unmet medical needs is seeking a Head of Quality and Pharmacovigilance Compliance.
Key Details
• Salary: $180,000 – $240,000 (Annual) BOE
• Benefits: Health, Vision, Dental, PTO and more
• Location: Remote (U.S. based) — Maryland/Mid-Atlantic area preferred
The Impact You’ll Make
• Strategic Oversight: Act as the primary advisor to the CEO and executive leadership on compliance risk exposure, trends, and remediation.
• Governance Leadership: Serve as the formal owner of the U.S. PV Quality System and the broader Quality Management System (QMS).
• Inspection Mastery: Lead FDA interactions, regulatory audits, and maintain a state of constant "inspection readiness."
• Enterprise Risk Management: Maintain a consolidated view of compliance across Medical Information, OPDP, DSCSA, and state-level requirements.
Who You Are
• Experienced: 7+ years in the pharma/biotech industry. (Experience in Rare Disease, Dermatology, or Neurology is strongly preferred).
• Regulatory Expert: Deep understanding of FDA/PhRMA promotional requirements and PV quality systems.
• Strategic Driver: Ability to drive accountability across functional teams and external partners without needing to perform "hands-on" execution.
• Mobile Leader: Comfortable with 60–70% overnight travel to engage with stakeholders and oversee multi-state operations.
Pay: $180,000.00 - $240,000.00 per year
Benefits:
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance
Application Question(s):
• Do you have understanding of FDA/PhRMA promotional requirements?
• Do you have experience in rare disease, dermatology, or neurology?
• Do you have knowledge of reimbursement and access issues?
• Do you have experience handling rare disease therapeutic products?
• Are you comfortable with a travel schedule that includes up to 70% overnight stays when required?
Education:
• Bachelor's (Required)
Experience:
• pharmaceutical/biotech/life-sciences industry: 7 years (Required)
Work Location: Remote