Senior Quality Leader, GMP & Regulatory Compliance

Regulatory Jobs; Illinois; Sur place; USD 140 000 - 200 000; Plein temps

Avantages offerts par ce poste

Benefits package

Résumé du poste

AbbVie is seeking a Senior Manager of Quality to lead the Quality Function within Operations. This role drives the effective implementation of AbbVie Quality Systems across incoming QA, Manufacturing QA, Validation, Quality Engineering, Control, Training and strategic initiatives, with budget ownership.

The incumbent provides regulatory and technical guidance to all plant departments, serves as SME for AbbVie plants, and communicates Quality initiatives to executives.

Qualifications

• Minimum Bachelor’s Degree required preferably in Physical or Life Sciences, Pharmacy, or Engineering; Master’s Degree or PhD preferred.
• Certified Quality Engineer or formal training in quality engineering or statistics is preferred
• 8+ years of combined experience in Manufacturing, QA, QC, R&D in pharmaceutical, biologics, device or chemical industry
• 4+ years of supervisory/technical leadership experience
• Must have a basic understanding and working knowledge of the physical and chemical characteristics of the products, including raw materials, manufactured at the plant
• Must be familiar with use of statistical quality systems, electronic document management and laboratory information management
• Must also be familiar with Quality policies as well as cGMP and other regulatory requirements
• Must have effective people management and communication skills necessary to supervise those reporting directly or through subordinates as well as establish and maintain effective working relationships among other key individuals in manufacturing, materials management, engineering, product development, Quality Systems, Product QA, Quality Control, Information Systems and Regulatory Affairs and must demonstrate sound judgment in evaluating and acting on day-to-day situations
• Strong communication Skills, both oral and written

Responsabilités

• 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.

Connaissances

Quality leadership

Regulatory compliance

Quality management

Strong communication

Formation

Bachelor's degree in Physical or Life Sciences, Pharmacy, or Engineering

Master’s Degree or PhD preferred

Description du poste

AbbVie is seeking a Senior Manager of Quality to lead the Quality Function within Operations. This role drives the effective implementation of AbbVie Quality Systems across incoming QA, Manufacturing QA, Validation, Quality Engineering, Control, Training and strategic initiatives, with budget ownership.

The incumbent provides regulatory and technical guidance to all plant departments, serves as SME for AbbVie plants, and communicates Quality initiatives to executives.