Director Post Market Quality

Job Description Purpose

The Director, Global Quality Complaint Operations leads the end to end complaint execution (includes complaint intake, processing, reportability, and medical device reporting) and is responsible for leading the global strategy for Post Marketing Quality Operations.

This role is responsible for all Abb Vie post‑market products (cosmetic, pharmaceutical, biologic, combination, devices) and investigation coordination of pre‑market device regulatory responsibility. The role oversees the health of the Operational Quality System, ensuring compliance with global regulatory requirements, medical device reporting, KPIs, and best‑in‑class timeliness and quality. It also has direct operational responsibility for capacity and demand planning for resource management, including new product introductions, market expansions, acquisitions, real‑time actions, and training programmes that cover new hires, process updates, new products and cross‑training.

The organisation partners with direct complaint execution functions (Device Safety, Manufacturing sites, labs, Product Security) and indirect support (Quality, Third‑Party Manufacturing, Product Support, Device Safety, Regulatory) and Global Commercial based on therapeutic areas including Patient Support Programs, Marketing, Pharmacovigilance, Global Medical Information and others to leverage PQC outputs to enhance the patient and customer experience.

• Provide global strategic direction and vision for the team located around the world responsible for the end‑to‑end complaint management process.
• Oversee global and US complaint handling processes to ensure complaints related to medical devices, combination products, pharmaceutical and biologics products are appropriately handled, evaluated, and reported to regulatory agencies worldwide.
• Implement and maintain the effectiveness of the quality system through quality policies, procedures and systems to support and maintain documented complaint investigations and associated CAPA investigations.
• Ensure complaint investigation and processing follow global complaint handling regulations and internal procedures, analyzing information and making decisions for reportability under regulations.
• Establish annual budgets, forecasts and resources; make necessary changes and plans to ensure annual budgets and long‑range plans are met.
• Handle escalated conversations with patients and/or physicians, avoiding litigious or compromising issues, providing information, education and assurance regarding product and service.
• Provide guidance, recommendations and implementation plans for adherence to new regulatory requirements or expectations; perform periodic audits of complaint handling records to ensure compliance.
• Represent the complaint handling functions during internal and external audits and inspections; serve as company representative to various US and international regulatory bodies.
• Monitor workflow to ensure quantity and quality are consistently met; initiate plans to maximize resource use and resolve issues; interview, hire, train employees and manage performance.
• Drive continuous improvement and develop and evaluate metrics and quality indicators to address underperformance and enhance performance.

• Bachelor’s degree required, preferably in a Life Science, Engineering, Physical Sciences, or related area.
• Advanced degree strongly desired.
• 12+ years of progressive Quality, Engineering, Medical Safety or Compliance experience with at least 7 years in a managerial capacity.
• Previous experience in medical device complaint management, product surveillance and regulatory event reporting.
• Ability to review, analyze, summarize and interpret data; draw conclusions; give written reports and oral presentations.
• Excellent written, verbal, listening, communication and team‑building skills.
• Knowledge of quality systems including CAPA and Field Corrective Action processes.
• Demonstrated knowledge and application of medical device adverse event reporting requirements.

At Abb Vie, we are committed to cultivating a work culture that promotes inclusion, diversity and personal growth. We have designed a benefits package with every aspect of life in mind.

Enhanced Health and Wellness Coverage:
Administrative staff have comprehensive medical and dental insurance.

Life Insurance:
Secure your family’s future with our life insurance policy.

Solidarity Association:
Join a community focused on mutual aid and enjoy the associated benefits.

Abb Vie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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