Senior Manager, Post Market Quality

About the role

The Senior Manager, Post Market Quality will lead AbbVie’s Global Complaint team, handling medical device and pharmaceutical combination product complaints worldwide. This role ensures compliance with global regulatory requirements and drives continuous improvement across complaint processing.

Key responsibilities

• Provide strategic direction and vision for a globally distributed complaint processing team.
• Oversee global and US complaint intake, investigation, and documentation for medical devices, combination products, pharmaceuticals, and biologics.
• Author response letters to customers and ensure records meet GMP and regulatory standards.
• Identify potentially reportable events and coordinate notifications to appropriate functional groups.
• Create formal documentation for regulatory filings (e.g., Form 3500A, Med Dev reports).
• Interface with third‑party manufacturers, healthcare professionals, internal stakeholders, and regulatory agencies.
• Lead or participate in projects focused on process improvements, new product launches, and issue resolution.
• Support leadership in strategy development and continuous improvement initiatives.

Required profile

• Bachelor’s degree in life sciences, engineering, or a related discipline.
• Proficiency in English at B2 level or higher.
• Extensive experience in post‑market quality, complaint handling, and regulatory compliance for medical devices or pharmaceuticals.
• Strong leadership skills with a global, future‑focused perspective.

Required skills

• Good Manufacturing Practice (GMP) standards.
• Regulatory documentation preparation (Form 3500A, Med Dev reports).
• Complaint intake, investigation, and reporting.
• Knowledge of medical device and pharmaceutical regulatory requirements.