Quality Senior Manager

Regulatory Toolkit; Chicago (IL); Sur place; USD 120 000 - 180 000; Plein temps

Avantages offerts par ce poste

Paid time off

Medical/dental/vision insurance

401(k)

Long-term incentive programs

Résumé du poste

AbbVie is seeking a Senior Manager, Quality to lead quality oversight for distribution and logistics across AbbVie-owned facilities and 3PLs. You will guide regulatory compliance, quality systems, and training in support of cGMP and FDA requirements.

You will manage a team of quality professionals, administer budgets, and partner with leadership on quality initiatives and issue resolution. Travel is expected up to 25%.

Responsabilités

• Oversee a team of Quality professionals responsible for quality assurance related to the distribution and logistics of products shipped from AbbVie-owned facilities and third-party logistics providers.
• Provide quality and regulatory compliance leadership for complex operations with high volume and product complexity, including biologics, medical devices, CRT, cold chain, and frozen products.
• Serve as the decision-making authority for job-specific aspects of the quality and regulatory compliance program across assigned sites.
• Ensure quality metrics and key performance indicators are aligned with corporate quality requirements and applicable regulatory requirements.
• Manage, organize, train, and supervise the Quality team to ensure effective functional performance.
• Provide regulatory and technical guidance to required departments and serve as a subject matter expert as needed.
• Communicate with leadership regarding quality management reviews, quality initiatives, and issue resolution.
• Develop and administer the annual operating budget for the Quality unit.
• Make quality decisions related to all aspects of distribution and logistics — including change management, process management, quality systems, and management review — to ensure compliance with cGMP, FDA, EU, DEA, and other applicable regulatory requirements.

Description du poste

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Purpose

The Senior Manager, Quality provides leadership and direction for the Quality function within Operations. This role is responsible for the effective implementation of AbbVie quality systems within their area of responsibility, including quality oversight of AbbVie-owned warehouses (AP5, AP15, and AP32), the 3PL network, transportation service providers, and quality-relevant suppliers supporting distribution and logistics. Accountabilities also encompass training, regulatory compliance, quality planning, and strategic initiatives. The Senior Manager, Quality leads a team of Quality professionals responsible for compliance and quality oversight across AbbVie-owned warehouses, service providers, and strategic initiatives. This position manages a budget and is accountable for maintaining high product quality while driving operational efficiency.

Responsibilities

• Oversee a team of Quality professionals responsible for quality assurance related to the distribution and logistics of products shipped from AbbVie-owned facilities and third-party logistics providers.
• Provide quality and regulatory compliance leadership for complex operations with high volume and product complexity, including biologics, medical devices, CRT, cold chain, and frozen products.
• Serve as the decision-making authority for job-specific aspects of the quality and regulatory compliance program across assigned sites.
• Ensure quality metrics and key performance indicators are aligned with corporate quality requirements and applicable regulatory requirements.
• Manage, organize, train, and supervise the Quality team to ensure effective functional performance.
• Provide regulatory and technical guidance to required departments and serve as a subject matter expert as needed.
• Communicate with leadership regarding quality management reviews, quality initiatives, and issue resolution.
• Develop and administer the annual operating budget for the Quality unit.
• Make quality decisions related to all aspects of distribution and logistics — including change management, process management, quality systems, and management review — to ensure compliance with cGMP, FDA, EU, DEA, and other applicable regulatory requirements.

25% Travel*

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 based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employer remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie 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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html