Manager, Quality

Company Description

Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at  Follow @abbvie on X, Facebook, Instagram, You Tube, Linked In and Tik Tok.

Responsible for leading, implementing, and improving Quality Management Systems (QMS) at manufacturing sites, ensuring regulatory compliance (FDA, ISO, EU MDR, MDSAP, GMP) and alignment with internal policies and corporate standards. Supervises multidisciplinary quality teams, promotes a culture of continuous improvement, manages risks, audits processes, and supports adaptation to new regulations. This role is key in ensuring product quality, patient safety, customer satisfaction, and achieving the company’s strategic business objectives.

Main Functions and Responsibilities:

• Lead and supervise Quality Assurance / Design Assurance / Quality Compliance / Quality Systems teams, managing development, training, resource allocation, and coaching.
• Establish, maintain, and improve the QMS, including documentation, procedures, CAPA, DHR, change control, specification management, and training.
• Manage internal and external audit programs (FDA, ISO, local authorities), prepare responses, action plans, and follow-up of findings; act as quality representative during regulatory audits.
• Implement and administer risk management systems and resolve non-conformities (NCMR, CAPA, Post-Market Surveillance).
• Ensure regulatory compliance with applicable regulations (21 CFR 820/803/806/411, ISO 13485/ISO 14971, MDSAP, EU MDR/GMP/SOX).
• Lead integration and deployment of digital systems and process improvement projects, digitalization, and operational efficiency.
• Monitor, analyze, and report key quality metrics, trends, and compliance status.
• Influence and collaborate with cross-functional teams (Manufacturing, R&D, Regulatory, IT, Engineering); act as technical reference for root cause analysis, validations, failure investigations, and risk management.
• Manage appropriate allocation of material and human resources for quality process compliance.
• Ensure compliance with EHS requirements and support a culture of safety and continuous improvement.
• Represent the quality area in strategic committees and management review meetings.
• Promote an inclusive, excellence-focused, and improvement-driven culture, ensuring recognition and motivation for the team.
• Stay updated on new regulatory standards; develop and implement plans to adapt the QMS as needed.
• Direct and ensure proper operation of specialized areas (Microbiology, laboratory, CAPA, audit, document center, validations, returned product analysis).
• Undertake additional responsibilities as assigned by senior management to achieve corporate objectives.

Key Requirements and

Qualifications:

• University degree in engineering, sciences, chemistry, biology, or related field; postgraduate degree preferred.
• 5–10+ years of experience in quality roles in the medical/pharmaceutical/biotech industry, with at least 2–5 years in management/leadership positions.
• Deep knowledge of QMS, FDA regulations, ISO 13485/ISO 14971, MDSAP, GMP, EU MDR, and similar standards.
• Strong experience in auditing, CAPA management, document control, validations, and risk management.
• Proficiency in English (oral and written); ideally, bilingual Spanish.
• Quality certifications (CQA, CQE, Green Belt, Risk Management) preferred.
• Advanced leadership, project management, communication, problem-solving, and team development skills.
• Proficient in IT tools (MS Office, QMS platforms), and digital quality systems.
• Ability to manage multiple projects, prioritize, and build consensus in multicultural and cross-functional environments.

At Abb Vie, we are committed to cultivating a workplace culture that promotes inclusion, diversity, and personal growth. We recognize that our…