Purpose
The Senior Manager, Quality provides leadership and direction to the Quality Function they are responsible for within Operations. This Sr. Manager role is responsible for the effective implementation of AbbVie Quality Systems for which they are responsible for. This could include: Incoming Quality Assurance of drugs and packaging materials, Manufacturing Quality Assurance, Validation of product and processes, Quality Engineering, Quality Control, Training, Regulatory Compliance, Quality Planning, Product Quality and strategic initiatives. The Sr. Manager of Quality would be expected to manage a budget and leads a team of quality professionals who are responsible for compliance and quality oversight for the plant and/or strategic initiatives. Expectations that the professional will maintain high quality levels on all products while achieving high efficiency.
Responsibilities
- Responsible for various aspects of quality assurance and quality control related to products produced at the plant. This will be at a large plant with high volume, high level of product complexity including multiple products at the site and may have the complexity of multiple types of productions (API, Fin Goods, Biologics, Packaging, Device, etc.).
- Represents the decision-making authority on job specific aspects of the Quality and Regulatory compliance program for the site.
- Ensures that product within the plant is consistently manufactured in conformance with corporate Quality requirements and all applicable regulatory requirements.
- Manages a team of quality professionals. Directly responsible for the effective organization, administration, training and supervision of their functional area.
- Provides regulatory and technical guidance to all departments in the plant and can be the SME for all AbbVie plants.
- Communicates with executive level for Quality Management Review, Quality Initiatives, etc.
- Responsible for the development and administration of the annual operating budget for the Quality Unit they are responsible for.
- Incumbent is responsible for quality decisions related to all aspects of the plant operation including facility design, laboratory controls and product specifications and to ensure that the area of their responsibility meets all cGMP, FDA, EU, DEA and other regulatory requirements.
- Incumbent is responsible for quality decisions related to all aspects of the plant operation including facility design, laboratory controls and product specifications and to ensure that the area of their responsibility meets all cGMP, FDA, EU, DEA and other regulatory requirements.