Director, Global Post Market Quality Operations
AbbVie · Heredia
Job description
About the role
The Director, Global Quality Complaint Operations leads end‑to‑end complaint execution for all AbbVie post‑market products, including cosmetics, pharmaceuticals, biologics, combination products, and medical devices. This senior position shapes the global strategy for post‑marketing quality and ensures compliance with worldwide regulatory requirements.
Key responsibilities
- Provide global strategic direction and vision for a worldwide complaint management team.
- Oversee complaint intake, processing, reportability, and medical device reporting across all product categories.
- Implement and maintain quality policies, procedures, and systems to support documented investigations and CAPA activities.
- Ensure compliance with global complaint handling regulations and internal standards.
- Manage capacity, demand planning, and resource allocation for new product introductions, market expansions, and acquisitions.
- Develop and deliver training programs for new hires, process updates, and cross‑training initiatives.
- Collaborate with manufacturing sites, labs, regulatory, pharmacovigilance, and commercial functions to enhance patient and customer experience.
Required profile
- Proven leadership experience in global quality and complaint management within the pharmaceutical or medical device industry.
- Deep understanding of regulatory requirements for medical devices, combination products, pharmaceuticals, and biologics.
- Strong analytical ability to assess reportability and drive corrective actions.
- Experience in budgeting, capacity planning, and resource management.
- Excellent communication skills to partner with cross‑functional teams worldwide.
Required skills
What we offer
- Opportunity to lead a global quality function at a leading biopharma company.
- Collaborative, innovative environment focused on patient impact.
- Competitive compensation and benefits package.
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Published 7 hours ago
Expires 1 month from now
5 views · 0 applications
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AbbVie
Heredia