Senior Manager, Lab Services

Senior Manager, Quality

The Senior Manager, Quality provides leadership and direction to the Quality Control Laboratories within Operations. This role is responsible for the effective implementation of Abb Vie Quality Systems, including Incoming Quality Assurance of drugs and packaging materials;
Validation of instruments, test methods, and test method transfers;
Quality Engineering;
Quality Control;
Training;
Regulatory Compliance;
Quality Planning;
Product Quality; and strategic initiatives. The Senior Manager of Quality is expected to manage a budget and lead a team of quality professionals who are responsible for compliance and quality oversight for the Quality Control Labs and strategic initiatives. The professional will maintain high quality levels on all products while achieving high efficiency.

• Responsible for various aspects of quality assurance and quality control related to products produced at the plant, which has high volume, high product complexity, and multiple types of productions (API, Finished Goods, Biologics, Packaging, Device, etc.).
• Represents the decision‑making authority on job‑specific aspects of the Quality and Regulatory compliance program for the Quality Control Labs.
• 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 Quality Control Labs and can serve as the SME.
• Communicates with executive level for Quality Management Review, Quality Initiatives, etc.
• Responsible for the development and administration of the annual operating budget and capital budget for the Quality Control Labs.
• Ensures that the area of responsibility meets all cGMP, FDA, EU, DEA and other regulatory requirements for facility design, laboratory controls, product specifications, and overall Quality Control operations.

• Minimum bachelor’s degree preferred in Physical or Life Sciences, Pharmacy, or Engineering; master’s degree or PhD 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.
• Familiarity with statistical quality systems, electronic document management and laboratory information management.
• Knowledge of quality policies and cGMP and other regulatory requirements.
• Effective people‑management and communication skills necessary to supervise direct reports and establish relationships with key individuals in manufacturing, materials management, engineering, product development, quality systems, QA, QC, information systems and regulatory affairs.
• Strong oral and written communication skills.

• Comprehensive package of benefits including paid time off (vacation, holidays, sick), medical, dental, vision insurance and 401(k) to eligible employees.
• Participation in short‑term incentive programs.

Abb Vie 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.

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