Senior Manager, Product QA is responsible for quality of Humira biologics drug product, combination products and medical devices to ensure business objectives are met with regards to on time delivery of product while assuring compliance to local, divisional and corporate policies and external agency regulations.
Quality responsibility includes products produced at AbbVie plants and by third party manufacturers TPM'sincluding active pharmaceutical ingredients APIssterile finished goods FGsas well as quality oversight over the entire supply chain. Provides strategic and functional leadership of all quality assurance activities related to product and support AbbVie's Third Party Manufacturing.
Maintains the primary quality lead for project activities and the team members within and outside of AbbVie to achieve on-time quality deliverables, high customer value, and profitable results. The incumbent is the primary driver for the quality and compliance aspects for product transfers and organization optimizations.
This involves working with cross functional groups both internally and externally to determine their business needs to optimize job functions and reduce Beautiful women Bramsche risk. In Ludwigshsfen to achieve this, the incumbent must recognize priorities, dependencies, and critical paths that are important to the sequencing of project activities.
This includes anticipating issues as the project progresses agenyc solving these problems quickly, effectively, and cost-efficiently. Functions as main Quality liaison between TPM's and AbbVie Operations in support of commercial operations, new product introductions and product transfers.
Establishes and maintains relationships and open communication with TPMs, AbbVie plants, affiliates and other functional groups.
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Possesses knowledge and skill set to operate within Steve Oberhausen dating website environment that requires a high degree of urgency, strong analytical and problem-solving skills, positive interpersonal skills, ability to manage multiple complex tasks simultaneously, and capable of performing as leaders, members and individuals.
Coordinates activities to support follow-up afency complaint trend investigations for non-medical and medical adverse events. Supports the management of exception documents and CAPA.
Completes management reviews with assigned TPM's that identify and address quality, operational, and organizational issues.
AbbVie Deutschland GmbH & Co. KG Ludwigshafen am Rhein
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