Laboratory Manager, Product Development QA

BioSpace; North Chicago (IL); Hybrid; USD 110,000 - 140,000; Full time

Benefits offered by this job

Medical coverage

401(k)

Job summary

AbbVie is seeking a Hybrid Product Development QA leader to oversee analytical QA for clinical supply releases. You will guide Lab QA, address complex analytical challenges with CMC teams, and drive process improvements.

The role requires strong regulatory knowledge, project management, and clear communication across functions. Candidates should have 6–8 years in QA/analytical sciences, familiarity with API GMP manufacturing, and the ability to lead audits and implement compliance changes across

Qualifications

• 6-8 years experience in QA, analytical sciences, or related field.
• Strong understanding of API and drug product GMP manufacturing in labs.
• Knowledge of US and international quality regulations.
• Experience in project management and coordinating complex activities.
• Excellent oral and written communication; able to present QA positions to leadership.

Responsibilities

• Lead Product Development QA from analytical perspective for clinical supply release.
• Support CMC teams by resolving complex analytical challenges.
• Provide leadership to Lab QA team.
• Drive process improvements by updating policies and procedures.
• Lead QA analytical audits and inspections; serve as QA SME.
• Develop, maintain, and report quality metrics to management.
• Review and approve specifications; manage investigations.
• Ensure compliance with regulations and implement changes.
• Approve laboratory investigations.
• Respond to regulatory requirements across locations.

Education

Bachelor's degree in life sciences or engineering

Master's degree preferred

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. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

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

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. Masters 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 clearlypresenting and justifying quality requirements throughout all levels of management

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 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, visithttps://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