Manager Post Market Quality Assurance F/M
AbbVie a pour mission de découvrir et d’offrir des solutions et des médicaments innovants pour répondre à des besoins importants en matière de santé aujourd’hui et relever les défis médicaux de demain. Elle met tout en œuvre afin d’avoir un impact remarquable sur la vie des gens dans divers aires thérapeutiques clés: l’immunologie, l’oncologie, les neurosciences, et les soins oculaires/les maladies de l'oeil, de même que dans le domaine de l’esthétique avec le portefeuille des produits et services d’Allergan Aesthetics. Pour en savoir plus sur AbbVie, visitez le site www.abbvie.com. Suivez @abbvie sur Twitter, Facebook, Instagram, YouTube et LinkedIn.
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.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
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