Manager Post Market Quality Assurance F/M

Under the responsibility of the Quality Director, your role will be to act as one of the Site Quality representatives for commercialized AbbVie products and the global supply chain, with a dedicated team under your supervision.

In this role, you will have the following responsibilities:

• Act as the primary quality representative for the global supply chain and make decisions regarding product quality in alignment with various stakeholders (both local and global)

• Oversee and implement the global post-market surveillance strategy, including the development and analysis of PSURs (Periodic Safety Update Reports) and the management of PMCF (Post Market Clinical Follow-up), in order to anticipate risks, identify areas for improvement, and guide organizational decisions

• Oversee and implement the global complaint management strategy and review of market signals by strengthening a proactive approach to anticipate and evaluate customer satisfaction

• Oversee and implement the supplier quality strategy to select, evaluate, and develop high-performing partners to meet our objectives of excellence, innovation, and compliance with standards • Be responsible for the implementation and maintenance of the quality system’s effectiveness by applying and maintaining quality policies, procedures, and systems within your scope

• Guarantee the coordination of activities related to major quality events, ensuring alignment, engagement, and involvement of global stakeholders in key decisions • Manage stability programs, integrate and leverage collected data, and guide actions to ensure product reliability and durability • Lead the implementation of trend reviews, issue quality recommendations supporting the vision and mission of AbbVie Quality

• Conduct audits, monitor KPIs, and deploy action plans

• Establish and manage the budget for your department

• Manage a multidisciplinary quality team. Engage and mobilize your team with a collaborative team-working, performance, and ownership mindset.

You have the following strengths to join us:

• Advanced scientific degree (Master’s degree or higher required) or pharmacist.
• Minimum of 10+ years in quality assurance operations management, regulatory affairs, operations, or technical support in a pharmaceutical environment.
• Knowledge of FDA, ISO13485 requirements for medical devices or pharmaceuticals.
• Fluent in English (spoken and written).
• Organizational/management skills and the ability to manage a team
• Strong interpersonal skills for effective communication and teamwork
• Ability to synthesize information and present it
• Analytical and problem-solving skills, positive interpersonal skills, ability to manage multiple complex tasks simultaneously, and act as a leader and team member.
• Solid knowledge in quality assurance/control, manufacturing, laboratory, technical support, regulatory affairs, and/or validation is required.

AbbVie 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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