Manager, Product Quality

Responsibilities

• Performs final quality decisions related to manufactured product lots for products and/or product lines prepared by Third Party Manufacturers and Suppliers.
• Participates in the development of global Product Quality Assurance strategy to support pharmaceuticals, biologics, devices, and combination products produced at AbbVie plants as well as third-party manufacturing (TPM) facilities. Implements agreed strategy.
• Bachelor's Degree in relevant Life Science or Engineering is required.
• Minimum of 8 years of total combined experience in Quality and Manufacturing.
• Knowledge in Biologics (parenteral manufacturing and visual inspection process) is highly desired.
• Experience with Supplier Management.
• Possesses knowledge and a skill set to operate within an environment that requires a high degree of urgency, strong analytical and problem-solving skills, positive interpersonal skills, negotiation, and conflict management skills, and the ability to manage multiple complex tasks simultaneously.
• Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting base

Benefits

Additional Information

Purpose : Responsible for quality of assigned products which may include small molecule pharmaceuticals and/or biologics products, 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 worldwide. Products include regulatory starting materials, Active Pharmaceutical Ingredients (API), Intermediates or Drug Products produced by AbbVie plants or by third-party manufacturers, In Licensing relationships, or Co-Marketing relationships. Develops in concert with Regulatory Affairs, the appropriate regulatory strategies for product brands. Grade is commensurate on level of overall responsibility.

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