Laboratory Manager, Product Development QA

AbbVie; North Chicago (IL); Hybrid; USD 140,000 - 190,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k) plan

Long-term incentive programs

Job summary

AbbVie is seeking a Product Development QA leader to drive analytical-focused release for clinical supply. Hybrid role based in North Chicago, IL and other AbbVie locations, supporting CMC teams and leading Lab QA activities.

The role emphasizes process improvement, QA audits, and rigorous compliance with US and international regulations. A strong API/quality systems background is essential for success in this position.

Qualifications

• Bachelor's degree or equivalent in life sciences or engineering; Master’s preferred.
• 6-8 years in QA/analytical sciences or related field.
• Strong understanding of API GMP manufacturing as applied to lab operations.
• Knowledge of US/international quality regulations.
• Experience in project management and cross-functional coordination.
• Collaborative, risk-based approach to problem solving.
• Effective oral and written communication of quality positions.
• Ability to present and justify quality requirements to management.

Responsibilities

• Support CMC teams in resolving analytical challenges through development phases.
• Provide leadership and daily support to the Lab QA team.
• Drive continuous process improvement by updating policies and procedures.
• Lead QA Analytical audit/inspection activities and support audits.
• Develop, maintain and report key quality metrics to Management.
• Lead analytical testing batch release; coordinate issue resolution.
• Review and approve excipient, drug substance and product specifications.
• Write/review/approve exception reports with high impact.
• Approve Laboratory investigations.
• Assess compliance to regulations and implement applicable process changes.

Skills

Quality assurance

Project management

Communication

Analytical thinking

Education

Bachelor's degree or equivalent experience

Master’s degree preferred

Tools

GMP understanding

Job 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.

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

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

This Hybrid role could be based in any of these AbbVie locations:

North Chicago, IL, Cambridge, MA, Irvine, CA, San Francisco, CA

Purpose:

Primarily responsible for leading Product Development QA from an analytical perspective in support of clinical supply release.

Responsibilities

• Support CMC teams in resolving complex technical Analytical challenges through various phases of development


• Provide leadership and daily support to the Lab QA team


• Drive continuous process improvement within Product Development QA by updating/authoring policies/processes/procedures and related documents


• Lead QA Analytical audit /inspection preparation activities and support the audits/inspections as the QA SME


• Develop, maintain, and report key quality metrics to Management


• Lead for analytical testing batch release; coordination and issue resolution


• Review and approval of excipient, drug substance and product specifications, including justification and revisions


• Write/review/approve exception reports, including high impact and complex ERs impacting multifunctional areas


• Approve Laboratory investigations


• Responsible for assessing compliance to regulations and industry practice and implementing applicable process changes

Qualifications

• Bachelor's degree or equivalent experience is required; typically, in life sciences or engineering. Master’s degree is preferred but is not required based on commensurate experience.


• 6-8 years of experience in function or related field, preferably with quality assurance and/or analytical sciences, or a combination thereof


• Strong understanding of Active Pharmaceutical Ingredients (API) and drug product GMP manufacturing as applied to laboratory operations is preferred, as well as an understanding of Quality Assurance principles and systems.


• Strong understanding of US and international regulations for quality systems and compliance, as applicable to investigational products


• Experience in project management, coordination, and planning of complex activities


• Ability to take a collaborative and risk-based approach to problem solving


• Effective use of oral and written communication skills to clearly communicate the quality position, and the actions necessary to resolve issues


• Capable of clearly presenting and justifying quality requirements throughout all levels of management

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 thisposting 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 employee remains in the Company's sole and absolute discretion unless anduntil 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