Quality Senior Manager

AbbVie Inc.; Illinois; On-site; USD 150,000 - 180,000; Full time

Benefits offered by this job

Benefits package

Job summary

AbbVie Inc. seeks a Senior Manager, Quality to lead the Quality Function within Operations.

This role oversees Quality Systems implementation across QA, QC, Validation, Training, and Regulatory Compliance while guiding a budget and a team of quality professionals to ensure regulatory alignment and high efficiency. The incumbent will act as SME for AbbVie plants, drive Quality initiatives with executives, and ensure compliance with cGMP, FDA, EU, and related regulations.

Qualifications

• Bachelor’s degree in Physical or Life Sciences, Pharmacy or Engineering required; Master’s 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.
• Familiar with statistical quality systems, electronic document management and laboratory information management.
• Must have effective people management and communication skills and knowledge of cGMP and regulatory requirements.

Responsibilities

• Responsible for various aspects of quality assurance and quality control related to products produced at the plant.
• Represents the decision-making authority on job specific aspects of the Quality and Regulatory compliance program for the site.
• Ensures product is consistently manufactured in conformance with corporate Quality requirements and regulatory requirements.
• Manages a team of quality professionals and provides training and supervision.
• Provides regulatory and technical guidance to all plant departments and can be the SME for all AbbVie plants.
• Communicates with executive level for Quality Management Review and Quality Initiatives.
• Responsible for development and administration of the annual operating budget for the Quality Unit.
• Quality decisions related to plant operations including facility design, laboratory controls and product specifications to meet cGMP, FDA, EU, DEA and other regulatory requirements.

Skills

Quality Assurance

Quality Control

Quality Engineering

Regulatory Compliance

cGMP

FDA knowledge

EU regulatory requirements

Statistical quality systems

Electronic document management

Laboratory information management

People management

Communication skills

Budget management

Leadership

Education

Bachelor’s Degree in Physical or Life Sciences, Pharmacy, or Engineering

Master’s Degree

PhD

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 at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

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

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 Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable 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