REMS Audit Oversight Lead

About the role

This is a U.S.-based remote role aligned to East Coast working hours. Some travel may be required.

Responsibilities

• Develop and manage a risk-based REMS audit compliance program for products and third-party partners.
• Plan and oversee execution of compliance, audits by a third party to assess compliance with REMS requirements, regulations, and internal standards.
• Trend audit findings and work with stakeholders to define and track corrective and preventative actions (CAPA).
• Serve as the subject matter expert during regulatory inspections and support inspection readiness activities.
• Create metrics and trend reports to identify systemic risks and recommend process improvements.
• Coach and mentor colleagues on audit methodology, REMS compliance, and quality expectations.

Requirements

• Must reside within territory for consideration with access to a major airport.
• Bachelor’s degree in life sciences, healthcare, quality, or related field.
• Minimum of 5 years’ experience in quality assurance, regulatory compliance, or audit within the pharmaceutical or healthcare industry.
• Direct experience with REMS programs, including Experience planning and overseeing REMS audits and managing CAPA follow-up.
• Experience with U.S. regulatory requirements for risk management and pharmacovigilance.

Qualifications

• Advanced degree in life sciences, pharmacy, public health, or related field.
• Strong written and verbal communication skills with experience presenting audit findings to stakeholders.
• Knowledge of pharmacovigilance systems and safety reporting requirements.
• Experience working with cross-functional global teams and third-party vendors and regulatory bodies.
• Experience with vendor oversight.
• Proficiency with data analytics, or quality metrics.
• Experience operating in environments requiring rapid operational escalation and high-volume audit activities.

Skills

Basic Qualification: Must reside within territory for consideration with access to a major airport. Bachelor’s degree in life sciences, healthcare, quality, or related field. Minimum of 5 years’ experience in quality assurance, regulatory compliance, or audit within the pharmaceutical or healthcare industry. Direct experience with REMS programs, including Experience planning and overseeing REMS audits and managing CAPA follow-up. Experience with U.S. regulatory requirements for risk management and pharmacovigilance.

Benefits

• Health care and other insurance benefits (for employee and family).
• Retirement benefits.
• Paid holidays.
• Paid vacation.
• Paid caregiver/parental and medical leave.

Pay

The US annual base salary for new hires in this position ranges from $126,750 to $211,250. The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role.

Schedule

This is a U.S.-based remote role aligned to East Coast working hours. Some domestic travel (up to 10%) may be required for stakeholder meetings.