Quality Senior Manager

AbbVie; Illinois; On-site; USD 140,000 - 180,000; Full time

Benefits offered by this job

Long-term incentive programs

Paid time off (vacation, holidays, etc

401(k)

Job summary

AbbVie in Illinois seeks a Senior Manager, Quality to lead the quality function in Operations. You will drive the implementation of AbbVie Quality Systems across Incoming QA, Manufacturing QA, Validation, Quality Engineering, and Compliance, ensuring product quality and regulatory adherence.

You will manage a team of quality professionals, develop budgets, provide SME guidance across plants, report to executives, and influence Quality Management Reviews.

Qualifications

• Candidates must have 8+ years in manufacturing QA/QC/R&D in pharma or related fields.
• Supervisory or technical leadership experience is required.
• Strong knowledge of cGMP, FDA, EU and other regulatory requirements.

Responsibilities

• Responsible for various aspects of QA/QC related to products at a large, high-complexity plant.
• Represent decision-making authority on Quality and Regulatory compliance at the site.
• Ensure products are manufactured in conformance with quality requirements and regs.
• Manage a team of quality professionals with training and supervision responsibilities.
• Provide regulatory and technical guidance to plant departments; serve as SME.
• Communicate with executives for QMR, Quality Initiatives and updates.
• Develop and administer the annual Quality Unit operating budget.
• Make quality decisions for plant operations to meet cGMP, FDA, EU, DEA and other regs.

Skills

Leadership

Quality management

Regulatory knowledge

Statistical methods

People management

Communication skills

Education

Bachelor's degree

Master's/PhD preferred

Tools

LIMS

Electronic document management

Quality systems training

Job description

Company Description

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 atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Job Description

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.

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

Additional Information

• 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

What AbbVie Has to Offer

Our work can—and does—have a tangible, lasting impact on millions of people. But it’s not just the results that matter. How we achieve them matters, too. Leading with purpose, we work to build a more sustainable future for generations to come. We do that by putting our expertise, resources and talent to work to make a real difference for patients, communities and our world.